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U.S. Department of Health and Human Services

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Enforcement Report for March 18, 2009

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

 

March 18, 2009
09-11

RECALLS AND FIELD CORRECTIONS:  FOODS CLASS I

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PRODUCT 
a) Abercrombie U.S.A. Grown "Fresh Roasted Peanuts", net wt 2 lbs. Product is packaged in a clear plastic bag with no UPC code listed, Recall # F-138-9;

b) Abercrombie U.S.A. Grown "Honey Roasted Peanuts", net wt 2 lbs. Product is packaged in a clear plastic bag with no UPC code listed. Recall # F-139-9
CODE
None
RECALLING FIRM/MANUFACTURER
Abercrombie Foods, Inc., Louisville, LA, by telephone on January 30, 2009 and press release on February 5, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corp. of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,000 lbs
DISTRIBUTION
AL
___________________________________
PRODUCT 
Margaritaville Island Lime Tortilla Chips, net wt. 13 ounce packages; UPC 647671310122, Recall # F-140-9
CODE
All lots with a best by date of December 6, 2008 or earlier.
RECALLING FIRM/MANUFACTURER
Recalling Firm: El Matador Tortilla Factory, Grand Rapids, MI, by press release, letter dated September 12, 2008 and by telephone between September 12, 2008 and September 15, 2008.
Manufacturer: Garden Fresh Salsa, Inc., Ferndale, MI. Firm initiated recall is complete.
REASON
The chips contain undeclared whey and buttermilk solids.
VOLUME OF PRODUCT IN COMMERCE
406,512 bags
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Giambri's brand Milk Chocolate or Dark Chocolate Peanut Butter Easter Eggs in boxes with Easter designs. No UPC codes: a) Petite Peanut Butter Eggs - these are bite sized Easter eggs packaged in a 1 lb. box. b) 12 count or 60 count "counter size" boxes sold only to wholesalers (these were also shipped in unlabeled brown shipper boxes) c) boxes containing a single 1/2 lb. (8 oz.) egg d) boxes containing a single 1 lb. egg. Recall # F-141-9;

b) Giambri's brand Assorted Chocolates which contain individual pieces of Milk Chocolate or Dark Chocolate Peanut Butter Truffles. The truffles are rectangular in shape and have a stylized letter "P" on the chocolate.  No UPC codes. The assorted chocolates were packaged in 8 oz., 1 lb. and 2 lb. sizes. Recall # F-142-9
CODE
Product was not coded. Last distribution date for this product was March 2008.
RECALLING FIRM/MANUFACTURER
Giambri's Quality Sweets, Inc., Clementon, NJ, by press on February 3, 2009 and letters e-mailed on February 3 through 6, 2009. Firm initiated recall is ongoing.
REASON
Product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
130 x 1 lb boxes, 13 x 60 count boxes, 238 x 12 count boxes, 972 individual pieces
DISTRIBUTION
PA, NJ and DE
___________________________________
PRODUCT 
a) Walgreens Cafe W Marathon Mix, Net Wt. 7 oz. (198 g); a trail mix packaged in a plastic bag; Item 219308, UPC 0 49022 41012 1 , Recall # F-143-9:
 
b) Walgreens Cafe W Super Energy Mix, Net Wt. 5 oz. (141 g) and 7 oz. (198 g); a trail mix packaged in a plastic bag; 5 oz. - item 122939, UPC 0 49022 39747 7 7 oz. - item 123533, UPC 0 49022 41011 4,  Recall # F-144-9:

c) Walgreens Cafe W Cranberry Crunch, Net Wt. 7 oz. (198 g); a trail mix packaged in a plastic bag; item 123534, UPC 0 49022 41013 8, Recall # F-145-9
CODE
a) and c) All Sell By dates prior to 1/31/210;
b) 5 oz. – All Sell By dates prior to 8/15/2009; 7 oz. – All Sell By dates prior to 1/31/2010;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walgreen Company, Deerfield, IL, by press release and electronically on February 2, 2009.
Manufacturer: Great Skott Foods, Inc., West Allis, WI. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corp. of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,202,856 – 5 oz. bags; 25,494 – 7 oz. bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
DeLuxe Chocolate Peanut Butter Delight Ice Cream, Chocolate Ice Cream with Peanut Butter Swirl and Chocolate Covered Peanuts. The product is in 3 gallon and 1/2 gallon sizes. The half gallons display a UPC of 75295-00010 on their lids, Recall # F-146-9
CODE
Mix codes 07-067, 09-080, 01-001 stamped in purple ink on the bottoms of the containers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mooresville Ice Cream Company, Mooresville, NC, by telephone, e-mail and visits beginning February 3, 2009.
Manufacturer: Pecan Deluxe Candy Co., Dallas, TX. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corp. of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
360 – ½ gal. and 68 – 3 gal. containers
DISTRIBUTION
NC and SC
___________________________________
PRODUCT 
Aqua Star Shrimp Appetizers. Package says SHRIMP APPETIZERS Ginger Shrimp Twists. Shrimp Purses. Sweet & Sour Wontons. Pad Thai Rangoons. Trans Fat Free. Includes Sweet Chili Dipping Sauce Oven Ready 20 Appetizers Net Wt 13.5 oz (380 g). UPC Code 7 31149 35063 2. Recall # F-147-9
CODE
Lot codes: 010 08254; 010 08255; 010 08256; 010 08257; 010 08282; 010 08283. Code Breakdown: 010 = packer identification 08 = julian year 254 = julian date
RECALLING FIRM/MANUFACTURER
Recalling Firm: Admiralty Island Fisheries, Inc. dba Aqua Star, Seattle, WA, by telephone on February 5, 2009.
Manufacturer: Thai Union Frozen Products, Samutsakorn, Thailand. Firm initiated recall is ongoing.
REASON
Products contain undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
2,590 cases each containing 12 13.5 oz. retail boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Golden Dragon Fish brand Frozen Cooked Mackerel Fish, Net. Wt. 250 g. Product of Vietnam. The product is packed in a plastic bag (appears to be vacuum packed) and basket, Recall # F-148-9
CODE
Uncoded
RECALLING FIRM/MANUFACTURER
Recalling Firm: K-Fat Inc., Brooklyn, NY, by press release on January 16, 2009.
Manufacturer: Vinh Hiep Co., Ltd., Ho Chi Minh City, Vietnam. Firm initiated recall is complete.
REASON
The imported processed fish was found to be uneviscerated based on sampling & analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
86 cases (40 x 250 packages per case
DISTRIBUTION
NY, NJ
___________________________________
PRODUCT 
Hershey's Goo Goo Peanut Butter Ice Cream, half gallon, UPC 2468203340. The product is shipped two units wrapped in natural brown paper labeled with product and code date. Recall # F-149-9
CODE
Code: 7110
RECALLING FIRM/MANUFACTURER
Hershey Creamery Co., Harrisburg, PA, by telephone on February 2, 2009 and press release on February 4, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corp. of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
27638 units
DISTRIBUTION
CT, KY, MA, ME, NH, OH, PA, VA, VT
___________________________________
PRODUCT 
a) Georgia Salted Skinless Peanuts in 11 oz. and 4 lb. cans. The cans do not bear UPC codes, Recall # F-150-9;

b) Georgia Honey Roasted Peanuts in 11 oz. and 4 lb. cans. The cans do not bear UPC codes, Recall # F-151-9
CODE
Unknown
RECALLING FIRM/MANUFACTURER
Recalling Firm: Georgia Peanut Commission, Tifton, GA, by letter and press release on February 3, 2009.
Manufacturer: Peanut Corp. of America, Blakely, GA. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corp. of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,420 cans 11 oz. skinless; 1,296 4 lb. skinless; 1,920 cans 11 oz. Honey Roasted; 336 cans 4 lb. Honey Roasted
DISTRIBUTION
AL, AR, CA, FL, GA, IL, KY, MD, MA, MI, MO, NE, NH, NY, PA, SC, TN, TX, WV, WI and DC
___________________________________
PRODUCT 
a) Peanut Butter Stick, 8 oz, also pails with Peanut Butter Stick, 25 lbs. hand written on it, Recall # F-152-9;

b) Blanton’s Homemade Candies, Peanut Brittle, Net Wt. 8 oz., Recall # F-153-9;

c) Blanton’s Homemade Candies, Sugar Free Peanut Brittle, Net Wt. 4 oz., Recall # F-154-9
CODE
The product is not coded
RECALLING FIRM/MANUFACTURER
Blanton’s Homemade Candies, Sweetwater, TN, by telephone beginning on January 16, 2009 and February 12, 2009 and by press release  on January 21, 2009 and February 13, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut products recalled because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,400 lbs Peanut Butter Sticks; 195 lbs Peanut Brittle
DISTRIBUTION
TN, VA, GA, FL, NC
___________________________________
PRODUCT
a) a) Ilchester Shropshire Blue; 12 oz.; 7 - 9 oz.; 1/8 lb.; 1/16 lb. Also packaged as b) Trader Joe's: Trader Joe's Shropshire Blue Cheese - film wrapped and c) Cropwell Bishop Creamery Shropshire Blue. Recall # F-155-9;

b) a) Ilchester Baby Blue Stilton; 2/5 lb.; b) Ilchester Blue Stilton; 1/8 lb.; 2/9 lb.; 1/9 lb.; 1/16 lb.; 18/1 lb.; 6/3.5 oz. crock; Also packaged as c) Global Cheese Market Stilton: 7 to 9 oz.; 1/5 lb;  d) Trader Joe's Blue Stilton, film wrapped; and e) Cropwell Bishop Creamery Blue Stilton, Recall # F-156-9
CODE
a) a) Lot 3052822700, exp. 2/10/09; 7 to 9 oz., lot 3052828700, exp. 4/19/09; 1/8 lb., lot 3052835200, exp. 4/27/09; 1/16 lb., lot 3375821700, exp: julian code 8217; b) Purchased on or before 01/04/2009; c) Purchased on or before 12/31/2008;

b) a) Lot 3375834000, 3375829500; exp.: Julian code 8340, 8295;  b) Lot 3375828400, exp: julian code 8284; 2/9 lb., lot 3375828400, 3375821700, 3375833300, 3375829400, 3375827800, 3375824500, 3357816400; Exp: Julian code 8284, 8217, 8333, 8294, 8278, 8245, 8164. 1/9 lb., lot 3375833600, 3375829400, 3375824500, 3758162000, 3375825200, exp: julian code 8336, 8294, 8245, 8162, 8252; 1/16 lb., lot 3375825400m exp. julian code 8254;18/1 lb, lot 3052829500, 3052830800, Exp date: 4/19/09, 5/2/09; 6/3.5 oz crock, lot 2216832300, exp. 3/26/09; c) Lot 714568, 714720, exp. 3/22/09, 3/29/09, lot 713939, 715973, 716368, exp. 3/9/09, 5/2/09, 5/17/09; d) Purchased on or before 12/31/08; e) Purchased on or before 12/31/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Cheese Company, Carlstadt, NJ, by telephone and e-mail on December 31, 2008, press release on January 27, 2009 and by letter on January 29, 2009.
Manufacturer: Cropwell Bishop Creamery, Nottingham, UK. Firm initiated recall is ongoing.
REASON
Cropwell Bishop Creamery found Listeria monocytogenes in a vat in which these products were manufactured.
VOLUME OF PRODUCT IN COMMERCE
16,789 cases – all sizes and varieties
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS CLASS II

___________________________________
PRODUCT 
a) Elk Meat, Elk Tenderloin, Frozen in plastic vacuum packaging. Each package is approximately 2 lbs., and each case is approximately 16 lbs.; Item number 755125, Recall # F-129-9;

b) Elk Meat, Elk Trim, Frozen; Item number 755155, Recall # F-130-9;  

c) Elk Meat, French Rack, Chilled. Item number 755132, Recall # F-131-9;

d) Elk Meat, Nude Denver Leg. Item number 755122, Recall # F-132-9;

e) Elk Meat, New York Strip Steak, Chilled. Item number 755128, Recall # F-133-9;

f) Elk Meat, Flank Steak Frozen. Item number 755131, Recall # F-134-9;
CODE
Elk Meats with production dates of December 29, 30, and 31
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sierra Meats, Reno, NV, by telephone on January 29, 2009 and press release on February 9, 2009.
Manufacturer: Noah’s Ark Holding, LLC, Dawson, MN. Firm initiated recall is ongoing.
REASON
Elk products contain meat derived from an elk confirmed to have Chronic Wasting Disease (CWD).
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NV, CA, TX, CO, NY, UT, FL, OK
___________________________________
PRODUCT 
a) Peanut butter cookies packaged in clear compostable bags labeled in part: “two tarts***Peanut Butter Creams peanut butter oatmeal cookies filled with peanut butter cream***Ingredients: Butter (milk) flour***granulated sugar***”. Cookies are packaged either 6 or 12 cookies per pack, Recall # F-135-9;

b) Hazelnut cookies packaged in clear compostable bags labeled in part: “two tarts***Hazelnut Baci hazelnut shortbread domes filled with bittersweet chocolate ganache***Ingredients: Butter (milk,) unbleached wheat flour***sugar, hazelnuts, chocolate***”, Recall # F-136-9;

c) Cookies packaged in clear compostable bags labeled in part: “two tarts***Cappuccino Creams espresso shortbread filled with cinnamon buttercream*** Ingredients: Butter (milk,) unbleached wheat flour***sugar***”, Recall # F-137-9
CODE
Product is not coded.
RECALLING FIRM/MANUFACTURER
Two Tarts Bakery, Inc., Portland, OR, by visit on February 5, 2009. Firm initiated recall is ongoing.
REASON
Products list butter and cream as ingredients but do not list milk as the source of the butter and cream as required by Food Allergen Labeling and Consumer Protection Act  (FALCPA).
VOLUME OF PRODUCT IN COMMERCE
a) 4-6 packs, 2-12 packs;
b) 2-6 packs, 2-12 packs;
c) 3-6 packs, 2-12 packs
DISTRIBUTION
OR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Bellaspas Tablets, Phenobarbital USP, 40mg; Ergotamine Tartrate USP, 0.6mg; Levorotary alkaloids of belladonna 0.2mg; 100 and 500 count, Rx only, Recall # D-208-2009
CODE
Lot numbers: T020A06A, exp. 11/08; T020A06B, exp. 11/08; T076D06A, exp. 11/08; and T076D06B, exp 11/08
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville AL, by letters on September 15, 2008. Firm initiated recall is ongoing.  
REASON
Subpotent; 18month Stability
VOLUME OF PRODUCT IN COMMERCE
16,416 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Otomar Otic Drops (Chloroxylenol 1 mg/mL, Hydrocortisone 10 mg/mL, Pramoxine HC1 10 mg/mL), 15 mL Multi Dose Dropper Bottle. NDC 0682-9090-15, Recall # D-209-2009
CODE
Lot number: 70304
RECALLING FIRM/MANUFACTURER
Elge, Inc., Rosenberg, TX, by letter on November 3, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; 18 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
3,958 bottles
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0332-09
CODE
Units: W044408100447, W13747
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by facsimile and letter on August 18, 2008. 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
IL, FL
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0384-09
CODE
Units: 3404778, 3416050
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by e-mail on May 1, 2006. 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
Austria
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0401-09
CODE
Unit: 2560768
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on April 7, 2005. 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 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0462-09
CODE
Units: 4054101 (part 1) and 4054101 (part 2)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on July 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0469-09
CODE
Units: FQ87866, FQ92115
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on February 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0492-09
CODE
Unit: 3676615
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated May 9, 2005. 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
CA

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0504-09
CODE
Unit: 1678567 (split unit)
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by facsimile on July 14, 2008. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the cytomegalovirus (CMV) but were collected from a donor who previously tested positive for CMV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0556-09
CODE
Unit: 55R66157
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by electronic notification on January 2, 2008 or by facsimile on January 3, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0557-09
CODE
Unit: 7028052
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., Long Island City, NY, by telephone and facsimile on July 18, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Removed, Recall # B-0561-09  
CODE
Unit: 5703030
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville, FL, by telephone on February 14, 2004. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0562-09
CODE
Unit: 72F262104
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Brooksville, FL, by fax on June 27, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inverness, FL. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0563-09

CODE
Unit: 72F262085
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Brooksville, FL, by fax on June 23, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inverness, FL. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0565-09
CODE
Units: 2117459, 2118085
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated May 16, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking an NSAID (Trilisate), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0567-09
CODE
Unit: LW88882
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter on December 2, 2008. Firm initiated recall is complete.
REASON
Blood product, with incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0572-09
CODE
Unit: 9756286
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on June 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to at increased risk for variant Creutzfeldt - Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0573-09
CODE
Unit: 53GM64970
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on October 3, 2008 followed by a letter dated October 9, 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
MD

__________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced. Recall # B-0575-09;
b) Platelets Leukocytes Reduced. Recall # B-0576-09;
c) Plasma Frozen. Recall # B-0577-09
CODE
a), b), and c) Unit: 29FK66627
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by telephone on August 6, 2008 and by follow-up letter dated August 12, 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
3 units
DISTRIBUTION
VA, NC 
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0578-09
CODE
Unit: FH52042
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter dated July 23, 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
VA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0579-09
CODE
Units: W089808000276 (part 1 and 2), GP25257
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter on July 1, 2008 and August 11, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
VA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0584-09
CODE
Unit: Y54293
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated February 20, 2008. Firm initiated recall is complete.
REASON
Blood product, incorrectly labeled as S-antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-0585-09;
b) Fresh Frozen Plasma, Recall # B-0856-09
CODE
a) and b) Unit: KS75939
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter dated July 21, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-0587-09;
b) Platelets Pheresis Leukocytes Reduced. Recall # B-0588-09
CODE
a) Unit: KT83107; b) Unit: KT83107 (Part A and B)
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter dated May 8, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
VA
___________________________________
PRODUCT 
a) Red Blood Cells. Recall # B-0594-09;
b) Platelets. Recall # B-0595-09
CODE
a) and b) Units: N96123
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated June 20, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who emigrated from an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA and NY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0596-09
CODE
Unit: 18GL49295
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on November 6, 2007 and follow-up letter dated November 15, 2007, or by e-mail on November 6, 2007. 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
MI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0598-09
CODE
Unit: 18GW08422
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on November 17, 2007 with follow-up letter dated November 21, 2007, or by e-mail on November 17, 2007. 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
MI

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT 
Fresh Frozen Plasma, Recall # B-0434-09
CODE
Unit: 72F369663
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on April 18, 2008. Firm initiated recall is complete.
REASON
Blood product, processed from Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0435-09
CODE
Unit: 6242345
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by fax on December 1, 2006. 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
Switzerland
___________________________________
PRODUCT 
GTI Diagnostic HLA Typing Trays. (10 x 0.5 ml ABC COMPLEMENT, GTI 72, GTI 72 C, GTI 72 BL, GTI 72 L, GTI 72OR, GTI 96C, GTI 96, GTI B27, GTI B27-1); (20.0.5 mL ABC COMPLEMENT, GTI 72AB1&AB2, GTI 72 ABC1&ABC2); (10 x 0.5 mL DR COMPLEMENT, GTI DR); (10 HLA Typing Trays, GTI C1). Recall # B-0485-09
CODE
Code 72(Lot # 66.7, 67.3, 67.6, 67.7, 67.8. 67.9); 72 C (Lot # 32.2, 32.3, 32.5, 32.6, 32.7); 72 BL (Lot # 34.8, 34.9); 72L (Lot # 10.6, 10.7, 10.8); 72OR (Lot # 10.3); 96C (Lot # 53.2, 53.4); 96 (Lot # 85.4, 85.8, 85.9); B27 (Lot # 16.1, 16.2, 16.3); B27-1 (Lot # 4.0); 72AB1&AB2 (Lot # 15.5, 15.6); 72 ABC1&ABC2 (Lot # 27.1, 27.2, 27.4); DR (Lot # 54.6, 54.7, 54.9, 55.0); C-1 (Lot # 10.8, 10.9)
RECALLING FIRM/MANUFACTURER
Genetic Testing Institute, Inc., Waukesha, WI, by letter dated January 12, 2009. Firm initiated recall is ongoing.
REASON
GTI Diagnostic HLA Typing Trays, with weak or low reactivity reactions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17,101
DISTRIBUTION
Nationwide, Canada, Germany, Italy, Australia, Dominican Republic, Banglandesh, India, Belgium, Mexico, Lebanon
___________________________________
PRODUCT 
Cryoprecipitated AHF, Recall # B-0552-09
CODE
Unit: 040GT62581
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of America Region, Peoria, IL, by telephone on July 25, 2008 and follow up letter dated August 22, 2008 and. Firm initiated recall is complete.
REASON
Blood product, stored at an unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

___________________________________
PRODUCT 
Source Plasma, Recall # B-0554-09
CODE
Units: 363026528, 36025409, 363023783, 363023443, 363023005, 363021567, 363025014, 363024089, 363020712, 363020282, 363021171, 363018914, 363017946, 363017245, 363016390, 363014703, 363014255, 363013716, 363013057, 363012436, 363012092, 363003589, 363002661, 363000713, I74061562, I74061285, I74054258
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by facsimile on November 8, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0555-09
CODE
Unit: 55R66157
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by electronic notification on January 2, 2008 or by facsimile on January 3, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
__________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0569-09
CODE
Unit: 22FK96652
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on July 29, 2008. Firm initiated recall is complete.
REASON
Blood product, which was Co(b+) antigen positive but labeled as Co(b-) antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
__________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0570-09
CODE
Units: 22GG08156, 22LC54797, and 22KZ67206
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on August 19, 2008. Firm initiated recall is complete.
REASON
Blood products, which were Cw(+) antigen positive but labeled as Cw(-) antigen negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA, NJ
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0571-09
CODE
Unit: 9756286
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on June 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to at increased risk for variant Creutzfeldt - Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0574-09
CODE
Unit: 53GM64970
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by electronic mail on October 3, 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
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0597-09
CODE
Unit: 18GL49295
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on November 6, 2007 and follow-up letter dated November 15, 2007, or by e-mail on November 6, 2007. 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 
Recovered Plasma, Recall # B-0599-09
CODE
Unit: 18GW08422
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on November 17, 2007 with follow-up letter dated November 21, 2007, or by e-mail on November 17, 2007. 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

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT 
a) Light Diagnostics SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121, For in Vitro Diagnostic Use.. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet, Recall # Z-0953-2009;

b) Light Diagnostics Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a component in the Kit Catalog #3121 Simulfluor Flu A / Flu B DFA kit, Recall # Z-0954-2009
CODE
a) Lot Numbers: JBC1531415, TR1480748, and TR1501924;
b) Lot Numbers: JBC1531414, TR1458084, TR1480746, JBC1531421, JH1534500, TR1501923, TR1417106, and TR1422506
RECALLING FIRM/MANUFACTURER
Millipore, Corp., Temecula, CA, by telephone and letter on November 24, 2008. Firm initiated recall is ongoing.
REASON
Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use may lead to a potential misdiagnosis of influenza B.
VOLUME OF PRODUCT IN COMMERCE
662 units
DISTRIBUTION
Nationwide and countries of Canada, Mexico, Italy, Belgium, Germany, France, Spain, and United Kingdom
___________________________________
PRODUCT 
Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile; REF 5020-06-001. Component used to augment uni- and bi- compartmental defects and is manufactured from Ti-6A1-4V Alloy, Recall # Z-0996-2009
CODE
Lot number: 1635572
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated January 29, 2009 and email on February 19, 2009.
Manufacturer: Zimmer Austin, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON
The package contains 11 mm screws instead of the specified 6 mm screws.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide and Germany
___________________________________
PRODUCT 
a) Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile; REF 3511. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon, Recall # Recall # Z-1010-2009;

b) Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile; REF 3513. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon, Recall # Z-1011-2009;

c) Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5.5 Fr, 20 mm, sterile; REF 3515. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon, Recall # Z-1012-2009
CODE
a) Lot numbers: 12012906, 12013569 and 12039341;
b) Lot numbers: 12001574 and 12002381;
c) Lot numbers: 11988198 and 11989069
RECALLING FIRM/MANUFACTURER
Boston Scientific, Corp., Spencer, IN, by letter dated January 8, 2009. Firm initiated recall is ongoing.
REASON
The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
VOLUME OF PRODUCT IN COMMERCE
294 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1014-2009;

b) Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; REF 8351510. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1015-2009;

c) Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1016-2009;

d) Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; REF 8351512. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1017-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, Warsaw, IN, by letters dated January 9, 2009. 
Manufacturer: Medtronic Sofamor Danek USA Inc., Memphis, TN. Firm initiated recall is ongoing.
REASON
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
VOLUME OF PRODUCT IN COMMERCE
4,110 connectors and 43 sets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Stryker Cordless Driver 3 Handpiece; REF 4300. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1021-2009;

b) Stryker Rotary Handpiece, Single Trigger, for use with Stryker System 6; REF 6203. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1022-2009;

c) Stryker Rotary Handpiece, Single Trigger, for use with Stryker System 6; REF 6203-000-000S1. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1023-2009;

d) Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6; REF 6205. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1024-2009;

e) Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6; REF 6205-000-000S1. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1025-2009;

f) Stryker Reciprocating Saw, For use with Stryker System 6; REF 6206. Product is a linear cutting device used for cutting bone and bone related tissue. Recall # Z-1026-2009;

g) Stryker Sternum Saw, for use with Stryker System 6; REF 6207. The product is a linear cutting device used for cutting bone and bone related tissue including the sternum. Recall # Z-1027-2009;

h) Stryker Sagittal Saw, for use with Stryker System 6; REF 6208. Note: The product label declares the product to be a handpiece. The product is an oscillating cutting device used for cutting bone and bone related tissue. Recall # Z-1028-2009;

i) Stryker Sagittal Saw, for use with Stryker System 6; REF 6208-000-000S4. The product is an oscillating cutting device used for cutting bone and bone related tissue. Recall # Z-1029-2009;

j) Stryker Precision Oscillating Tip Saw, for use with Stryker System 6; REF 6209. The product is an oscillating cutting device used for cutting bone and bone related tissue. Recall # Z-1030-2009
CODE
a) Serial numbers: 723505023 through 804326503;

b) Serial numbers: 0614504853 through 0825902483;

c) Serial numbers: 0817003173 through 0825905983;

d) Serial numbers: 0615001103 through 0826001573;

e) Serial numbers: 0807117993 through 0811212433;

f) Serial numbers: 0613702313 through 0826201253;

g) Serial numbers: 0613902933 through 0826101223;

h) Serial numbers: 0615000953 through 0826200893;

i) Serial numbers: 0801802893 through 0801802913;

j) Serial numbers: 0620602123 through 0825317713
RECALLING FIRM/MANUFACTURER
Stryker Instruments Division of Stryker Corp., Portage, MI, by letter dated October 10, 2008. Firm initiated recall is ongoing.
REASON
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
VOLUME OF PRODUCT IN COMMERCE
25,893 units
DISTRIBUTION
Nationwide and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey
___________________________________
PRODUCT 
a) Integra Mosaik Putty, 15cc, Catalog # PTY10256. Recall # Z-1034-2009;

b) Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021. Recall # Z-1035-2009
CODE
a)  Lot numbers: 105B00135019, 105B00135020, 105B00135021, and 105B00135022;

b) Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826
RECALLING FIRM/MANUFACTURER
Integra LifeSciences, Corp., Plainsboro, NJ, by letters on January 21, 2009. Firm initiated recall is ongoing.
REASON
Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
VOLUME OF PRODUCT IN COMMERCE
119 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide. Indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3. Recall # Z-1060-2009
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter on August 6, 2008.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba, PR, Firm initiated recall is ongoing.
REASON
Reported incidents of needle retraction failure.
VOLUME OF PRODUCT IN COMMERCE
40,168 units
DISTRIBUTION
Nationwide and countries of Australia, New Zealand, China, Austria, Denmark, Finland, France, Germany, Italy, Kuwait, Lebanon, Norway, Qatar, Russian Federation, Spain, Sweden, Switzerland, and United Kingdom
___________________________________
PRODUCT 
Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only. Recall # Z-1091-2009
CODE
All lots beginning in 722601, Exp. 08/09. (Lots 722601, 722601-009, 722601-017, 722601-035, 722601-057, 722601-072, 722601-081, 722601-084, 722601-085, 722601-092, 722601-093, 722601-094, 722601-134, 722601-136, 722601-168, 722601-185, 722601-232, 722601-233, 722601-254, 722601-255, 722601-318, 722601-337, and 722601-361)
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letter dated November 3, 2008. Firm initiated recall is ongoing.
REASON
The product is unable to maintain the specification for linearity through the shelf life of the product.
VOLUME OF PRODUCT IN COMMERCE
1500 liters
DISTRIBUTION
Nationwide and countries of Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela
___________________________________
PRODUCT 
a) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System; The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications. Recall # Z-1092-2009;

b) Innova 4100 / 4100 IQ, The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications. Recall # Z-1093-2009
CODE
a) Lot numbers: 82416120006, 4103323100, 82416120005, and 214324INNOVA2;

b) Lot number: 757398INNOVA
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by on site visits from March 6, 2008 – December 19, 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MD, TX, VA and China

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT 
AcuSnare Polypectomy Soft Snare, Order number SASM-1, packed 5 boxes, 10 units per box. This device is used with an electrosurgical unit for endoscopic polypectomy. Recall # Z-1059-2009
CODE
Lot number: W23594445 and W2594446, Exp. Date: 10-2011
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by letter on/about January 21, 2009. Firm initiated recall is ongoing.
REASON
The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
VOLUME OF PRODUCT IN COMMERCE
10 boxes (100 snares)
DISTRIBUTION
MI, NY, WI and Australia

END OF ENFORCEMENT REPORT FOR March 18, 2009

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