• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for September 22, 2010

September 22, 2010                                                                                        10-37

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Chef's Cupboard Chicken with Rice Soup in 10.5 oz cans. Recall # F-2831-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bay Valley Foods, Westchester IL, by press release and email on July 30, 2010.
Manufacturer: Bay Valley Foods, LLC., Pittsburgh, PA. Firm initiated recall is ongoing.  
REASON
Undeclared egg and wheat allergens.
VOLUME OF PRODUCT IN COMMERCE
107,280 cans
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Milton's Multi-Grain Bread, in 24 oz plastic bag or in a two pack of 2 24 oz loaves in plastic bag. Recall # F-2832-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Earthgrains Baking Company, Oakland, CA, by press release on August 20, 2010. Firm initiated recall is ongoing.
REASON
Undeclared Milk Allergen-- Product contains undeclared buttermilk.
VOLUME OF PRODUCT IN COMMERCE
46,900 loaves
DISTRIBUTION
CA, AZ, NV
___________________________________
PRODUCT
Fresh Express Veggie Lover's Salad; a packaged fresh salad composed of Iceberg Lettuce, Romaine Lettuce, Carrots, Pea Pods, Red Cabbage and Radishes; UPC 0 71279 28100 1, production code I208,  12 oz. Bag. Recall # F-2833-2010
CODE
Use By August 10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresh Express Incorporated, Salinas, CA, by press release in conjunction with the Ohio Department of Agriculture on August 10, 2010.
Manufacturer: Fresh Express, Franklin Park, IL. Ohio initiated recall is complete.
REASON
One package of Fresh Express Veggie Lover's Salad was found positive for Listeria monocytogenes by the Ohio Department of Agriculture.
VOLUME OF PRODUCT IN COMMERCE
2,825 cases
DISTRIBUTION
Il, IN, KS, KY, MD, MA, MI, MO, NJ, NY, OH, PA and WI. It may have been redistributed to AR, CT, DC, IA, ME, MN, MS, NE, NH, RI, TN, VA, VT, WV

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
QUESO COTIJA Cotija Cheese, Wt 14 oz. Recall # F-2830-2010.
CODE
NONE
RECALLING FIRM/MANUFACTURER
Mexicali Cheese Corp., Woodhaven, NY, by a Consumer Alert on August 6, 2010. New York initiated recall is completed.
REASON
The Cotija Cheese was found to be contaminated with Staphylococcus aureus based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
29 - 14 oz. bags
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
1) Barq's Root Beer, 20 fl. oz (1.25 PT) 591 mL plastic bottles. Recall # F-2814-2010;

2) Fanta Caffeine Free, Grape Flavored Soda, 20 fl. oz. (1.25 PT) mL plastic bottles. Recall # F-2815-2010;

3) Fanta Caffeine Free, Orange Soda, 20 fl. oz. (1.25 PT) mL, and 2 liter plastic bottles. Recall #F-2816-2010;

4) Fanta Caffeine Free, Strawberry Flavored Soda, 20 fl. oz. (1.25 PT) mL, and 2 liter plastic bottles. Recall #F-2817-2010;

5) Mello Yello, Citrus Flavored Soda, 20 fl. oz. (1.25 PT) mL plastic bottles. Recall #F-2818-2010;

6) Minute Maid Pink Lemonade, 20 fl. oz. (1.25 PT) mL plastic bottles. Recall #F-2819-2010;

7) Minute Maid Lemonade, 20 fl. oz. (1.25 PT) mL and 2 liter plastic bottles. Recall #F-2820-2010;

8) Minute Maid Fruit Punch, 2 liter plastic bottles. Recall #F-2821-2010;

9) Pibb Xtra, 20 fl. oz. (1.25 PT) mL, and 2 liter plastic bottles. Recall #F-2822-2010;

10) Sprite, Lemon Lime Soda, 20 fl. oz. (1.25 PT) mL, and 2 liter plastic bottles. Recall # F-2823-2010;

11) Vault, Citrus Soda with a Kick, 20 fl. oz. (1.25 PT) mL plastic bottles. Recall #F-2824-2010;

12) Vault Red Blitz, Berry Soda with a Kick, 20 fl. oz. (1.25 PT) mL plastic bottles. Recall #F-2825-2010;

13) Coca Cola Classic, 20 fl. oz. (1.25 PT) mL, and 2 liter plastic bottles. Recall #F-2826-2010;

14) Cherry Coke, 20 fl. oz. (1.25 PT) mL plastic bottles. Recall #F-2827-2010;

15) Caffeine Free Coca-Cola Classic, 2 liter plastic bottles. Recall #F-2828-2010;

16) Vanilla Coke, 20 fl. oz. (1.25 PT) mL plastic bottles. Recall #F-2829-2010
CODE
1) AUG0910TN thru NOV0110TN 29BHT20;
2) AUG0910TN thru NOV0810TNA (20 oz.) and AUG0910TN thru NOV0810TNB;
3) AUG0910TN thru NOV0810TNA (20 oz.) and AUG0910TN thru NOV0810TNB;
4) AUG0910TN thru NOV0110TN (20 oz.) and AUG0910TN thru NOV0810TNB;
5) AUG0910TN thru NOV0110TN;
6) AUG0910TN thru JAN0311TN;
7) AUG0910TN thru JAN3111TN and AUG0910TN thru JAN3111TN;
8) AUG0910TN thru JAN3111TN (20 fl. oz.) and AUG0910TN thru JAN3111TN;
9) AUG0910TN thru NOV0810TNA (20 oz.) and AUG0910TN thru NOV0110TN;
10) AUG0910TN thru NOV0810TNA (20 oz.) and AUG0910TN thru NOV0810TNB;
11) AUG0910TN thru NOV0810TN;
12) AUG0910TN thru NOV0110TN;
13) AUG0910TN thru NOV0810TNB (20 oz.) and AUG0910TN thru NOV0810TNA;
14) AUG0910TN thru NOV0110TN;
15) AUG0910TN thru NOV0110TN;
16) AUG0910TN thru NOV0110TN
RECALLING FIRM/MANUFACTURER
Coca Cola & Ent, Atlanta, GA, by phone and email on/about August 15, 2010. Firm initiated recall is complete.
REASON
The High Fructose Corn Syrup was found to be contaminated with extraneous matter.
VOLUME OF PRODUCT IN COMMERCE
551,534 cases of 20-oz products (24 bottles per case) and 469,243 cases of 2 liter products (8 bottles per case)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT   
Arrow Brand Medicated Oil & Embrocation, or Aceite Medicinal "La Flecha" (also labeled in Chinese), supplied in 6 mL, 12 mL, 20 mL, and 40 mL clear glass bottles. Product codes: Flecha # 1, product # 2411, 40 mL bottle; Flecha # 2, product # 2413, 20 mL bottle; Flecha # 3, product # 2409, 12 mL bottle; Flecha # 4, product # 2421, 6 mL bottle. Recall # D-888-2010
CODE
The product bears no lot codes or expiration dates.
RECALLING FIRM/MANUFACTURER
Recalling Firm: J J J Distributors, Elizabeth, NJ, by letters on June 8, 2010.
Manufacturer: Da Chon Hua Trading, Santo Domingo, Dominican Republic. Firm initiated recall is ongoing.  
REASON
Labeling: Label Lacks Warning or Rx Legend: FDA issued a warning to consumers not to purchase the product due to flawed labeling which may mislead consumers to ingest product orally. The product contains ingredients that may be toxic if ingested.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT   
Daytrana (methylphenidate transdermal system), CII, 15 mg, 30 transdermal patches/box, Rx only, NDC 54092-553-30. Recall # D-889-2010
CODE
Lot # 40794, Exp 11/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shire Pharmaceuticals, Inc., Wayne, PA, by letter on July 19, 2010.
Manufacturer: Noven Pharmaceuticals, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Miscalibrated and/or Defective Delivery System: The lot being recalled was found to be out of specification for mechanical peel force of the adhesive liner during stability testing, which could cause patients or caregivers to have difficulty removing the liner.
VOLUME OF PRODUCT IN COMMERCE
65,776 boxes (30 patches per box)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT   
Colace (Docusate Sodium) Liquid 1% Stool Softener; 1 fl oz (30 mL); NDC 67618-102-30. Recall # D-890-2010
CODE
Lot numbers: 8T5534, exp 11/2010; 9J6397, exp 6/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: P F Laboratories, Inc., Totowa, NJ, by letter on June 3, 20101.
Manufacturer: Wellspring Pharmaceutical Canada, Oakville Ontario, Canada. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: OOS result for benzophenone during testing at the manufacturer.
VOLUME OF PRODUCT IN COMMERCE
18, 264 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT   
Red Blood Cells. Recall # B-1616-10
CODE
Unit: 17KQ94839
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN, by fax on October 24, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1704-10
CODE
Unit: 16KQ07343
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on September 17, 2008 and by letter dated September 23, 2008. Firm initiated recall is complete.
REASON
Blood product, with an unacceptable total hemoglobin level, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-1864-10
CODE
Unit:  1578310
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on May 26, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2138-10;
2) Recovered Plasma. Recall # B-2139-10;
3) Cryoprecipitated AHF. Recall # B-2140-10;
4) Platelets. Recall # B-2141-10
CODE
1), 2), 3), 4) Recall # 9733924
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on February 1, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for residing in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX, NJ
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-2220-10
CODE
Units: 1608767 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on March 12, 2008. 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
MN
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2242-10
CODE
Unit: 17KZ94378
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by fax and e-mail on August 15, 2008.
Manufacturer: The American National Red Cross – North Central Region, Saint Paul, MN. 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
MN, IL
___________________________________
PRODUCT   
1) Red Blood Cells. Recall # B- 2259-10;
2) Fresh Frozen Plasma. Recall # 2260-10;
3) Platelets. Recall # B-2261-10
CODE
1) Units: 0983811; 0925333; 0791235; 0762317;
2) and 3) Units: 0983811; 0925333; 0762317
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter and fax September 10, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
MN, Switzerland
___________________________________
PRODUCT   
1) Red Blood Cells. Recall # B-2263-10;
2) Fresh Frozen Plasma. Recall # B-2264-10
CODE
1) Units: 1578662; 1531803; 1432765; 1394285; 1339416; 1297814; 1272548; 1248728; 1225506; 1201355;

2) Unit: 1432765
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on September 25, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
MN, FL, PA, Switzerland
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2266-10;  
2) Cryoprecipitated AHF. Recall # B-2267-10;
3) Red Blood Cells. Recall # B-2268-10;
4) Fresh Frozen Plasma. Recall # B-2269-10
CODE
1) Units: 1383294; 1326800;
2) Unit: 1481740;
3) Units: 1481740; 1411487; 1251745; 1119907; 1084331; 1028598;
4) Units: 1383294; 1119907; 1084331
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter and fax on August 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
MN, IL, VA, VT, FL, Switzerland

___________________________________
PRODUCT   
Red Blood Cells. Recall # B-2300-10
CODE
Unit: W001607702825
RECALLING FIRM/MANUFACTURER
Recalling Firm: Department of the Air Force, Wright Patterson AFB, OH, by letter dated April 8, 2008.
Manufacturer: Depart of Air Force 88th Medical Group SGQC WPAFB, Wright Patterson AFB, OH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Japan
___________________________________
PRODUCT   
Source Plasma. Recall # B-2301-10
CODE
Units: TA2138532, TA2138777, TA2139318, TA2139602, TA2140185, TA2140451, TA2140949, TA2141240, TA2141918, TA2142211, TA2144215, TA2144502, TA2145030, TA2146597, TA2146724, TA2147425, TA2147506, TA2148251, TA2148363, TA2149220, TA2149499, TA2150384, TA2150652, TA2151231, TA2151695, TA2152094, TA2152603, TA2152982, TA2153432, TA2153750, TA2154323, TA2154574, TA2155154, TA2155679, TA2156109, TA2156546, TA2156911, TA2157206, TA2157634, TA2158017, TA2158273, TA2158827, TA2159071, TA2159621, TA2159850, TA2160451, TA2160674, TA2161214, TA2161373, TA2161817, TA2161953, TA2163325, TA2163554
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana, LLC, Gallup, NM, by letter dated July 25, 2008.
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
England
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2302-10
CODE
Units: R08951; P90041; P90041
RECALLING FIRM/MANUFACTURER
Blood Center of Northcentral Wisconsin, Inc., Wausau, WI, by fax on January 2, 2007.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2313-10;
2) Fresh Frozen Plasma. Recall # B-2314-10
CODE
1) and 2) Unit: 24FN05975
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, River Valley Region, Louisville, KY, by letter dated January 4, 2006.
Manufacturer: The American Red Cross Blood Services, River Valley Region, Louisville, KY. Firm initiated recall is complete.
REASON
Blood products, processed from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY, IN
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2315-10
CODE
Unit: 24FC42760
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, River Valley Region, Louisville, KY, by telephone on December 19, 2005 and follow up letter dated December 29, 2005.
Manufacturer: American Red Cross Blood Services, River Valley Region, Louisville, KY. Firm initiated recall is complete.
REASON
Blood product, processed from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT   
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-2317-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-2318-10
CODE
1) Unit: 7738617(BAG C);
2) Units: 7738617(BAG A); 7738617(BAG B)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., Long Island City, NY, by telephone on November 23, 2007 and fax on November 28, 2007.
Manufacturer: New York Blood Center, Inc., Elmsford, NY. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with S. warneri, Bacillus sp. and S. mitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ, NY
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2329-10
CODE
Unit: W0352081278735
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on October 14, 2008 and by follow-up letter on December 10, 2008. Firm initiated recall is complete. 
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2333-10;
2) Platelets. Recall # B-2334-10
CODE
1) and 2)Unit: 5530330
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on August 14, 2008 and by letter dated August 27, 2008. 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   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2338-10;
2) Plasma Frozen. Recall # B-2339-10
CODE
1) and 2) Unit: 5039861
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated September 21, 2007 or by electronic notification on September 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI, Switzerland
___________________________________
PRODUCT   
Source Plasma. Recall # B-2345-10
CODE
Units: 0460357449, 0460356724, 0460355653, 0460354856, 0460352918, 0460352199, 0460351391, 0460350581, 0460350041, 0460348746, 0460347855, 0460347081, 0460346029, 0460345620, 0460334014, 0460333080, 0460331872, 0460330887, 0460329694, 0460328948, 0460326365, 0460325904, 0460324467, 0460323879, 0460322893, 0460321787, 0460319987, 0460317998, 0460314808, 0460313024, 0460312130, 0460311815, 0460310665, 0460309955, 0460309236, 0460308552, 0460307976, 0460307033, 0460306130, 0460305683, 0460304705, 0460304287, 0460297767, 0460296635, 0460292931, 0460292351
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Dallas, TX, by facsimile on June 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
IL, Germany, Switzerland
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2347-10
CODE
Unit: 42LY11143 (part a and b)
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Cleveland, OH, by telephone on February 4, 2008 and by follow-up letter on February 7, 2008.
Manufacturer: American Red Cross Blood Services, Cleveland, OH. Firm initiated recall is complete.
REASON
Blood products, for which quality control testing was not completed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT   
Anti-k (Murine Monoclonal), ALBAclone; packaged in 2ml volumes in glass dropper bottles. Recall # B-1972-10
CODE
Unit: V090019
RECALLING FIRM/MANUFACTURER
Alba Bioscience Limited, Liberton, Edinburgh, by telephone and follow-up letters dated April 15, 2010. Firm initiated recall is ongoing.
REASON
Anti-k (Murine Monoclonal), with a potential for false positive reactions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
GA, MA, NY, NV, VA
___________________________________
PRODUCT   
Blood Grouping Reagent, Anti-K (cellano), Alba, Bioscience. Product Code: Z137U. Recall # B-1973-10
CODE
Lot numbers: VO79465 Exp. Date: 25 Sep. 2010 and VO84266 Exp. Date: 04 Apr 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hemo Bioscience, Inc., Durham, NC, by letter on/about May l0, 2010.
Manufacturer: Alba Bioscience (formerly Diagnostics Scotland), SNBTS, Liberton, Edinburgh, Firm initiated recall is ongoing.
REASON
Anti-k (Murine Monoclonal), with a potential for false positive reactions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
125 units
DISTRIBUTION
AL, AR, CA, FL, GA, IL, IN, KY, LA, MI, MN, NC, NE, NJ, NY, OH, OK, IN, TX, WI
___________________________________
PRODUCT   
Anti-k (Murine Monoclonal) IVD. Recall # B-1974-10
CODE
Unit: 783119001, Exp 6/16/2010  
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biotest Medical Diagnostics GmbH, Dreieich, Germany, by letter dated May 5, 2010.
Manufacturer: Biotest AG – Dreieich, Dreieich, Germany. Firm initiated recall is complete.
REASON
Anti k (Murine Monoclonal), with a potential for false positive reactions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
85 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Source Plasma. Recall # B-2004-10
CODE
Units: 0550014879, 00550015737
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Nashville, TN, by fax on March 28, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously tested reactive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Spain
___________________________________
PRODUCT   
Source Plasma. Recall # B-2006-10
CODE
Units: 0530314000; 0530313702; 0530312747; 0530312490; 0530293287; 0530269467; 0530268986
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Lexington, KY, by fax on September 18, 2007.
Manufacturer: CSL Plasma, Lexington, KY. Firm initiated recall is complete.
REASON
Blood products collected from a donor who was previously permanently deferred for unsuitable test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC
___________________________________
PRODUCT   
Source Plasma. Recall # B-2239-10
CODE
Unit: FZ073631
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Wisconsin, Milwaukee, WI, by fax on August 6, 2008. 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
Austria
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2243-10 
CODE
Unit: 17KZ94378
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by fax and e-mail on August 15, 2008.
Manufacturer: The American National Red Cross – North Central Region, Saint Paul, MN. 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
MN, IL
___________________________________
PRODUCT   
1) Plasma. Recall # B-2254-10;
2) Platelet Pheresis Leukocytes Reduced Irradiated. Recall # B-2255-10;
3) Red Blood Cells. Recall # B-2256-10;
4) Fresh Frozen Plasma. Recall # B-2257-10;
5) Fresh Frozen Plasma (Apheresis). Recall # B-2258-10
CODE
1) Units: W001308009956; W001308009957; W001308009958; W001308009959; W001308009960; W001308009966; W001308009967; W001308009968; W001308009969; W001308009970; W001308009974; W001308009992; W001308010004; W001308010007; W001308010010; W001308010014; W001308010015; W001308010016; W001308010017; W001308010018; W001308010019; W001308010020; W001308010021; W001308010022; W001308010023; W001308010026; W001308010029; W001308010030; W001308010034; W001308010035; W001308010036; W001308010038; W001308010040; W001308010042; W001308010044; W001308010045; W001308010047; W001308010048; W001308010049; W001308010050; W001308010051; W001308010052; W001308010053; W001308010054; W001308010055; W001308010058; W001308010059; W001308010061; W001308010062; W001308010064; W001308010066; W001308010068; W001308010069; W001308010070; W001308010073; W001308010074; W001308010075; W001308010076; W001308010078; W001308010079; W001308010080; W001308010081; W001308010082; W001308010083; W001308010121; W001308010122; W001308010184; W001308010185; W001308010187; W001308010189; W001308010190; W001308010191; W001308010192; W001308010194; W001308010195; W001308010196; W001308010198; W001308010200; W001308010202; W001308010203; W001308010204; W001308010205; W001308010206; W001308010209; W001308010210; W001308010211; W001308010213; W001308010214; W001308010241; W001308010242; W001308010243; W001308010244; W001308010245; W001308010246; W001308010247; W001308010248; W001308010249; W001308010250; W001308010251; W001308010252; W001308010253; W001308010255; W001308010256; W001308010258; W001308010261; W001308010262; W001308013314; W001308014365; W001308014383; W001308014388; W001308014389; W001308014390; W001308014392; W001308014394; W001308014400; W001308014413; W001308014415; W001308014416; W001308014417; W001308014423; W001308014424; W001308014425; W001308014428; W001308014429; W001308014430; W001308014448; W001308014456; W001308014461; W001308014465; W001308014467; W001308014479; W001308014482; W001308014483; W001308014484; W001308014485; W001308014486; W001308014487; W001308014488; W001308014490; W001308014491; W001308014496; W001308014497; W001308014498;

2) Units: W001308201170; W001308201173; W001308201180; W001308201190; W001308201608;W001308201613;W001308201614;W001308220234B ; W001308220351A; W001308220353;

3) Units: W001308009991; W001308009993; W001308010036; W001308010041; W001308010204; W001308010205; W001308010206; W001308010209; W001308010211; W001308010214; W001308010241; W001308010242; W001308010243; W001308010244; W001308010245;W001308010246; W001308010247; W001308010248; W001308010261; W001308010262; W001308010268; W001308010271; W001308014391; W001308014396; W001308014399; W001308014400; W001308014401; W001308014404; W001308014409; W001308014416; W001308014426; W001308014433; W001308014471; W001308014476; W001308014481;W001308014482; W001308014483; W001308014484; W001308014485; W001308014486; W001308014487; W001308014488; W001308014490; W001308014491; W001308014492;

4) Units: W001308009975; W001308009979; W001308009990; W001308009994; W001308009996; W001308010002; W001308010003; W001308010008; W001308010013; W001308010031; W001308010032; W001308010033; W001308010037; W001308010041; W001308010043; W001308010057; W001308010201; W001308010212; W001308010215; W001308014363; W001308014367; W001308014372; W001308014397; W001308010216;

5) Units: W001308201181C; W001308201182A; W001308201182B; W001308201182C; W001308201183A; W001308201183B; W001308201183C; W001308201184A; W001308201184B; W001308201184C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Department of the Air Force, San Antonio, TX, by electronic mail on November 24, 2008 and by letter on November 26, 2008.
Manufacturer: Department of Air Force – BB/HT, San Antonio, TX. Firm initiated recall is complete.
REASON
Blood products, tested with expired reagents for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
232 units
DISTRIBUTION
TX, NY, VA
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2262-10
CODE
Unit: 0791235
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter and fax September 10, 2008. 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
MN, Switzerland
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2265-10
CODE
Units: 1578662; 1531803; 1394285; 1339416; 1297814; 1272548; 1248728; 1225506; 1201355
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on September 25, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
MN, FL, PA, Switzerland
___________________________________
PRODUCT   
1) Plasma Cryoprecipitated Reduced. Recall # B-2270-10;
2) Recovered Plasma. Recall # B-2271-10
CODE
1) Unit: 1481740; 1028598;
2) Units: 1411487; 1326800; 1251745; 1084331
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter and fax on August 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
MN, IL, VA, VT, FL, Switzerland

___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2309-10
CODE
Unit: 24GG16300
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, River Valley Region, Louisville, KY, by telephone on May 30, 2008.
Manufacturer: American Red Cross Blood Services, River Valley Region, Louisville, KY. Firm initiated recall is complete.
REASON
Blood product, prepared from a whole blood unit that had an extended bleed time documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit
DISTRIBUTION
IN
___________________________________
PRODUCT   
Source Plasma. Recall # B-2335-10
CODE
Unit: TA2130624
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana LLC, Texarkana, AR, by letter dated August 5, 2008. 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
England
___________________________________
PRODUCT   
Source Plasma. Recall # B-2359-10
CODE
Units: 4020335792, 4020335088, 4020333458, 4020332504, 4020330278, 4020329616, 4020325395, 4020324455, 4020312767, 4020310635, 4020309916, 4020307653, 4020306857, 4020305165, 4020304050, 4020301837, 4020300961, 4020298534, 4020279592, 4020276893, 4020269338
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma, Inc., Boca Raton, FL, by e-mail on March 25, 2008.
Manufacturer: CSL Plasma, Inc., Akron, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
Switzerland, Germany, IL
___________________________________
PRODUCT   
Cryoprecipitated AHF, Pooled. Recall # B-2366-10
CODE
Unit: W036308901247J
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on October 14, 2008. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
QCL-1000 Chromogenic Limulus Amebocyte Lysate, Part number 50-642E, packaged in 3 mL vials with QCL-1000 kit lots, part number 50-648U. Recall # B-2374-10
CODE
Reagent master lot # 0000073295 packaged with kit lots 0000092042 and 0000078333
RECALLING FIRM/MANUFACTURER
Lonza Walkersville, Inc.,        Walkersville, MD, by letter on January 19, 2009.  Firm initiated recall is complete.
REASON
QCL-1000 Chromogenic Limulus Amebocyte Lysate kit lots, with failed stability test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
459 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT   
1) FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1975-2010;

2) FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.  Recall # Z-1976-2010;

3) FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1977-2010;

4) FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1978-2010;

5) FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1979-2010;

6) FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1980-2010;

7) FLEXIMA Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1981-2010;

8) FLEXIMA Biliary Stent System, 8.5Fr-10cm, M00539270, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1982-2010;

9) FLEXIMA Biliary Stent System, 8.5Fr-12cm, M00539280, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.  Recall # Z-1983-2010;

10) FLEXIMA Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1984-2010;

11) FLEXIMA Biliary Stent System, 10Fr-5cm, M00539300, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1985-2010;

12) FLEXIMA Biliary Stent System, 10Fr-7cm, M00539310, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1986-2010;

13) FLEXIMA Biliary Stent System, 10Fr-10cm, M00539320, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1987-2010;

14) FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1988-2010;

15) FLEXIMA Biliary Stent System, 10Fr-15cm, M00539340, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1989-2010;

16) FLEXIMA Biliary Stent System, 11.5Fr-5cm, M00539350, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1990-2010

17) FLEXIMA Biliary Stent System, 11.5Fr-7cm, M00539360, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1991-2010;

18) FLEXIMA Biliary Stent System, 11.5Fr-10cm, M00539370, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1992-2010;

19) FLEXIMA Biliary Stent System, 11.5Fr-12cm, M00539380, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1993-2010;

20) FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1994-2010
CODE
1) Units: 13122098, 13133678, 13139309, 13144163, 13150255, 13157375, 13164676, 13169430, 13172078, 13180899, 13197546, 13213768, 13220736, 13233454, 13251259, 13262950, 13278674, 13291033, 13293589, 13301698, 13306620, 13317116, 13326762, 13329148, 13332362;

2) Units: 13132880, 13142201, 13143356, 13143796, 13146820, 13153528, 13157508, 13165567, 13166306, 13169774, 13185696, 13186362, 13191710, 13200597, 13207924, 13217669, 13218935, 13227088, 13229799, 13234431, 13246627, 13258629, 13260101, 13263374, 13273999, 13285644, 13294293, 13300613, 13304567, 13310993, 13316305, 13320676, 13330228, 13331583;

3) Units: 13130923, 13147139, 13155258, 13172079, 13178809, 13191065, 13192581, 13200707, 13207118, 13210374, 13218941, 13231809, 13248449, 13254037, 13263744, 13271644, 13279829, 13282008, 13327106;

4) Units: 13133460, 13154362, 13168576, 13175013, 13184394, 13199044, 13214124, 13230441, 13251823, 13266469, 13291034, 13303478, 13313446, 13328734

5) Units: 13132190, 13157130, 13187919, 13226335, 13250499, 13281255;

6) Units: 13127492, 13188449, 13198517, 13215725, 13241693, 13268177, 13290840, 13302012, 13312896;

7) Units: 13129052, 13136527, 13148927, 13152353, 13165576, 13174355, 13175965, 13181718, 13194146, 13208597, 13224138, 13237836, 13247858, 13254934, 13271239, 13272523, 13278365, 13286079, 13301029, 13319652, 13321957, 13333430;

8)  Units: 13078764, 13125342, 13137491, 13171350, 13184389, 13201388, 13209951, 13235129, 13258630, 13289326, 13297516, 13312893, 13316315, 13334405;

9) Units: 13138753, 13206659, 13242083, 13263971, 13303899, 13320064;

10) Units: 13203851, 13238594, 13266169;

11) Units: 13126729, 13142903, 13194255, 13203889, 13218136, 13246629, 13268286, 13282925, 13297734, 13309514, 13333432;

12) Units: 13126265, 13134127, 13156455, 13197956, 13204778, 13221991, 13237544, 13254937, 13257431, 13265291, 13284617, 13287900, 13294576, 13295957, 13305078, 13325445, 13325900;

13) Units: 13129051, 13135901, 13149225, 13157131, 13182469, 13188938, 13197790, 13205415, 13221830, 13227176, 13235130, 13268760, 13274658, 13287741, 13298813, 13304261, 13313988, 13331582;

14)  Units: 13130319, 13152012, 13194906, 13203641, 13223728, 13265646, 13298652, 13310506, 13329668;

15) Units: 13200352, 13240383;

16) Units: 13135723, 13168839, 13231287, 13322992;

17) Units: 13240906, 13282484;

18) Units: 13149648, 13260102;

19) Unit: 13284754;

20) Unit: 13250878
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Quincy, MA, by letter dated April 27, 2010.
Manufacturer: Boston Scientific Corp., Spencer, IN. Firm initiated recall is ongoing.
REASON
Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile.
VOLUME OF PRODUCT IN COMMERCE
13,259 units
DISTRIBUTION
Nationwide, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay

___________________________________
PRODUCT
The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting of natural or synthetic, non-metallic, sutures during surgery. Recall # Z-2239-2010
CODE
STLS 23C: Model numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022 STLS 35C: Model 102-138D, Lot Numbers: 907004 and 907008v
RECALLING FIRM/MANUFACTURER
Starion Instruments, Sunnyvale, CA, by letter dated March 9, 2010. Firm initiated recall is ongoing.
REASON
The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indicating the device is 'on".
VOLUME OF PRODUCT IN COMMERCE
218 units
DISTRIBUTION
CA, OH, MI, KS, MO, Italy, China, Kuwait, and Germany
___________________________________
PRODUCT   
CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients. Recall # Z-2242-2010
CODE
Lot # M538160
RECALLING FIRM/MANUFACTURER
Civco Medical Instruments, Inc., Kalona, IA, by letter date July 19, 2010. Firm initiated recall is ongoing.
REASON
Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.
VOLUME OF PRODUCT IN COMMERCE
22//12-cover boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma. Catalog #/Product # BC-1123. Recall # Z-2243-2010
CODE
Kit lot numbers: RN-27940, 33689, and 37260  
RECALLING FIRM/MANUFACTURER
 BioCheck, Inc., Foster City, CA, by letter dated July 15, 2010. Firm initiated recall is ongoing.
REASON
Products were marketed without 510 (k) for diagnostic use. Unapproved device.
VOLUME OF PRODUCT IN COMMERCE
187 kits
DISTRIBUTION
Nationwide and Canada, India, S Korea and UAE
___________________________________
PRODUCT   
1)  Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds. Recall # Z-2263-2010;

2) Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds. Recall # Z-2264-2010;

3) Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds. Recall # Z-2265-2010;

4) Philips M1026BT Gas Modules with manifolds. Recall # Z-2266-2010
CODE
1) Serial Number range ARYE-0014 to ASBC-0013;
2) Serial Number range ARZC-0202 to ASBE-0086;
3) Serial Number range 4614H27003 to 4614H28158;
4) Serial Number range 4614H27160 to 4614H28184
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover MA,
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Hewlett-Packard Strasse 2, Boblingen, Germany. Firm initiated recall is ongoing.  
REASON
The manifold seal in the Philips M1657B Water Trap used on the Philips M1013A IntelliVue G1, M1019A, IntelliVue G5, and Anesthesia Gas Modules M1026B/BT may be unintentionally removed when changing the traps. A missing seal may result in leakage and may cause incorrect monitor readings of inspiratory or expiratory gas levels.
VOLUME OF PRODUCT IN COMMERCE
4,299 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT   
Dimension Tacrolimus Flex Reagent Cartridge. Recall # Z-2407-2010
CODE
Lot Numbers: DC0306 (exp 11/2/10), CA0320 (exp 11/16/10), DA0334 (exp 11/30/10), GA0348 (exp 12/14/10)
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letters dated June 2010. Firm initiated recall is ongoing.
REASON
Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.
VOLUME OF PRODUCT IN COMMERCE
4,580 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT   
Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista System. Creatinine measurements are used in the diagnosis and treatment of renal diseases in monitoring renal dialysis, and as a calculation basis for other urine analytes. Catalog number K1270. Recall # Z-2419-2010
CODE
Lot number 09224AA  
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated February 2010. Firm initiated recall is ongoing.
REASON
The ECREA test results may be falsely elevated or depressed.
VOLUME OF PRODUCT IN COMMERCE
324 units
DISTRIBUTION
AZ, CA, FL, IA, IL, MT, NC, NY, OR, PA, TX, WI and countries of Belgium, Italy, Canada, Germany and the Netherlands
___________________________________
PRODUCT
CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer. Recall # Z-2421-2010
CODE
List 08H00-01, 08H00-03, PCB Assembly part number 8960167101
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, initiated a field correction on April 5, 2010. Firm initiated recall is ongoing.
REASON
Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.
VOLUME OF PRODUCT IN COMMERCE
926 units
DISTRIBUTION
Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong King, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela
___________________________________
PRODUCT   
DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. Recall # Z-2422-2010
CODE
119 units are identified with Site Numbers: 59667, 82641, 82681, 86222, 86987, 86988, 103893, 103894, 104465, 104937, 104938, 105367, 504989, 505545, 506776, 532141, 536043, 536913, 539410, 540477, 540996, 541079, 541086, 541856, 541857, 542605, 542606, 543430, 544119, 544135, 544487, 544632, 544634, 544658, 545606, 547799, 548185, 548186, 548245, 548391, 548392, 548670, 549294, 549418, 549428, 549651, 549876, 549877, 549912, 550016, 550021, 550071, 550229, 550262, 550271, 550343, 550352, 550357, 550359, 550361, 550362, 550363, 550414, 550415, 550417, 550418, 550547, 550828, 550846, 550874, 550878, 550891, 550937, 551006, 551022, 551574, 551668, 551673, 552375, 552378, 552380, 552404, 552457, 552641, 553014, 553272, 553273, 553421, 553424, 553573, 553607, 554063, 554335, 554354, 554359, 554422, 554449, 554517, 554711, 554714, 554771, 555163, 555164, 555534, 555685, 555754, 553017, 531994, 535549, 543218, 543847, 547216, 549742, 550312, 551522, 552507, 552876, 552914, and 555119
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated March 10, 2008.
Manufacturer: Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr. Hamburg, Germany. Firm initiated recall is complete.
REASON
When using DICOM print functionality, the printed images may contain data for the wrong patient.
VOLUME OF PRODUCT IN COMMERCE
119 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS III
___________________________________
PRODUCT   
Oxytetracycline Hydrochloride Soluble Powder, For use in drinking water only, packaged in 1400g (NDC 59320-002-08) or 1772g (NDC 59320-002-09) pouches. Recall # V-219-2010
CODE
Lot numbers: 475384, 475385, 475386, 475462, 475463, 475464, 475465, 475466, 475467, 475468, 475469, 475470
RECALLING FIRM/MANUFACTURER
Vetoquinol Prolab Inc., Princeville Quebec, Canada, by by telephone on August 17, 2010. Firm initiated recall is ongoing.
REASON
Foreign manufacturer of API was not approved.
VOLUME OF PRODUCT IN COMMERCE
5773 / 1772g pouches, 673 / 1400g pouches
DISTRIBUTION
IA

END OF ENFORCEMENT REPORT FOR SEPTEMBER 22, 2010

#