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U.S. Department of Health and Human Services

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Enforcement Report for July 23, 2008

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.

July 23, 2008
08-29

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
Cantaloupes, Product of Honduras. Cantaloupes are packed in cardboard cartons with the brand name "Mike's Melons" or "Mayan Pride", Recall # F-446-8
CODE
No codes
RECALLING FIRM/MANUFACTURER
Central American Produce, Pompano Beach, FL, by press release on March 24, 2008 and followed with letter and telephone. Firm initiated recall is complete.
REASON
Products have been linked to an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
97,216
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
a) Fresh Cut cantaloupe is packed into plastic cups and or trays (platters) ranging in size from 5 oz to 4 lb.
    Fresh cut product is packaged with the following brand name labels: Frosty Fresh, Fresh Hand Cut,
    Fruit on the Go, Highland Park, Brueggers Bagels, Sid Wainer & Son, Hannaford, Garden
    Highway Plant #P-005, Recall # F-447-8;
b) Cut cantaloupe packaged as mixed with other fruits. packed into plastic cups and or trays (platters)
    ranging in size from 5 oz to 4 lb. Fresh cut product is packaged with the following brand name labels:
    Frosty Fresh, Fresh Hand Cut, Fruit on the Go, Highland Park, Brueggers Bagels, Sid Wainer & Son,
    Hannaford, Garden Highway Plant #P-005, Recall # F-448-8;
c) Preserved Cantaloupes and Mixed Fruit Salad packed into plastic pails or jars ranging from 46 oz
    to 4 gallon. Preserved product is packaged with the following brand names: Frosty Fresh, Pebble Beach,
    Festival of Fruit, Cornucopia Sweet, Jambo Chef, Fowler Fruit Mix, Instantwhip, Syracuse Banana, and
    City Line Food Dist, Recall # F-449-8
CODE
a) and b) Sell by date of "3/29/08" or earlier;
c) Preserved product in pails is recalled with an expiration date of: "EXP APR 7 2008" to "EXP APR 22 2008", or a Julian date code of "08067" to "08082". Preserved product in jars are recalled with an expiration date of: "EXP APR 22 2008" to "MAY 7 2008", or a Julian date code of "08067" to "08082
RECALLING FIRM/MANUFACTURER
Jard Marketing Corp. Lawrence, MA, by telephone on March 24, 2008, follow up letters dated March 26, 2008 and by press release on March 28, 2008. Firm initiated recall is ongoing.
REASON
Products have been linked to an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
276,000 lbs
DISTRIBUTION
MA, NH, ME, VT, CT, RI, NY
___________________________________
PRODUCT 
1) Garden Highway brand Apple Blend in 24 oz cup, 4 per case, SKU 10250414, Recall # F-450-8;
2) Garden Highway brand Cantaloupe Chunks in 12 oz cup, 6 per case, SKU 10250185, in 24-oz. bowl,
     6 per case, SKU 10250189, Recall # F-451-8;
3) Garden Highway brand Fruit Medley in 32 oz. cup, 2 per case, SKU 10250424/24 oz cup, 4 per case,
    SKU 10250410/12 oz cup, 5 per case, SKU 10250404; Recall # F-452-8;
4) Garden Highway brand Fruit Mix in 12 oz cup, 6 per case, SKU 10250209/24 oz. bowl and cup,
    6 per case, SKU 10250214, Recall # F-453-8;
5) Garden Highway brand Fruit Party Carousel, 5 lb. tray, 3 per case, SKU 1020151, Recall # F-454-8;
6) Garden Highway brand Fruit Party Platter, 5 lb. tray, 3 per case, SKU 1020180, Recall # F-455-8;
7) Garden Highway brand Fruit Tray, 48 oz cup, 2 per case, SKU 1020429/2.5 lb tray, 3 per case,
    SKU 10250179, Recall # F-456-8;
8) Garden Highway brand Apple Fruit Medley in 32 oz. cup, 4 per case, SKU 10250382/12 oz cup,
    6 per case, SKU 10250102, Recall # F-457-8;
9) Garden Highway brand Fruit Snack Tray in 2 lb. cup, 4 per case, SKU 10250384, Recall # F-458-8;
10) Garden Highway brand Mango Medley, 12 oz cup, 6 per case, SKU10250371, Recall # F-459-8;
11) Garden Highway brand Honeydew/Cantaloupe mix, 12 oz cup, 6 per case, SKU 10250207/Honeydew/
      Cantaloupe mix 24 oz cup, 6 per case, SKU 10250208, Recall # F-460-8;
12) Garden Highway brand Island Medley, 12 oz cup, 6 per case, SKU 10250213, Recall # F-461-8;
13) Garden Highway brand Melon Medley 12 oz. cup, 6 per case, SKU 10250400, Recall # F-462-8;
14) Garden Highway brand Melon Mix 2/6 5 lb. cup, 2 per case, SKU 10211046; 12-oz. cup, 6 per case,
      SKU10250203; 24-oz. cup, 6 per case, SKU 10250212, Recall # F-463-8;
15) Garden Highway brand Melon Trio in 42 oz cup, 2 per case, SKU 10250426, Recall # F-464-8;
16) Raley's brand Cantaloupe/Honeydew/Watermelon in 11 oz cup/18 oz. cup, 4 per case,
      SKU 10210330/10210331, Recall # F-465-8;
17) Raley's brand Cantaloupe, 11 oz cup, SKU 10210332/18 oz cup, 4 per case, SKU 10210333,
      Recall # F-466-8;
18) Raley's brand Fruit Mix 44 oz. cup, 4 per case, SKU 10210334, Recall # F-467-8;
19) Raley's brand Island Medley 11 oz, 4 per case, SKU 10201614, Recall # F-468-8;
20) Raley's brand Melon Mix, 44 oz cup, 4 per case, SKU 10210320, Recall # F-469-8;
21) Raley's brand Mixed Fruit in 11 oz cup, 4 per case, SKU 10210338/in 18 oz cup, 4 per case,
      SKU 10210339, Recall # F-470-8;
22) Auburn Produce, Pacific Pre-Cut Produce, Safeway, and Vons Meat Service Center brands SW Fruit and
      Dip Kit, 5 lb. kit, SKU 10210076, Recall # F-471-8;
23) Safeway brand and Vons Meat Service Center brand SW Fruit Component, 5 lb kit, SKU 10215307,
      Pacific PreCut Produce brand 10-lb. kit, SKU 10215307, Recall # F-472-8;
24) Garden Highway brand Tropical Medley in 24 oz cup, 4 per case, SKU 10250412, Recall # F-473-8;
25) Taylor Farms brand 4 Way Medley in 5 lb tub, 2 per case, SKU 60005, Recall # F-474-8;
26) Taylor Farms brand Cantaloupe 5 lb. tub, 2 per case, SKU 60001/5 lb tub, 1 per case, SKU 52259,
      5 lb. tub, 2 per case, SKU 60006, Recall # F-475-8;
27) Taylor Farms brand PPC Fruit Kit 10# in 10 lb. tray or tub, SKU 59054, Recall # F-476-8;
28) Taylor Farms brand PPC Fruit Tray, 40 oz tray, 2 per case, SKU 59069, Recall # F-477-8;
29) Sysco brand Cantaloupe Chunks in 5 lb. tub, 2 per case, SKU 40001/4 lb tub, 3 per case,
      SKU 40033/ 5 lb. tub, 1 per case, SKU 40033,  5 lb. tray, product code 70055801051, Recall # F-478-8;
30) Sysco brand Fruit Medley 4 way, 5 lb. tub, 2 per case, SKU 40004, Recall # F-479-8;
31) Sysco brand Fruit Medley with grapes, 5 lb. tub, 2 per case, SKU 60006, Recall # F-480-8;
32) Taylor Farms brand Cantaloupe Chunk 5 lb. tub, 2 per case, SKU 38151; 20-lb buckets,
       product code 70054800901, Recall # F-481-8;
33) Taylor Farms brand 1" Cantaloupe Chunk, 5 lb tray, Product code 70055801051, and 1" Cantaloupe
      Chunk, 5-lb. tub, product code 70054802051, Recall # F-482-8;
34) Taylor Farms brand Cantaloupe cup, 7 oz, product code 23124806071, Recall # F-483-8;
35) Taylor Farms brand Fruit Medley Tray, 5 lb., product code 68054801051, Recall # F-484-8;
36) Sysco brand Fruit Medley Tray, 2.5 lb., product code 68055704251, Recall # F-485-8;
37) Taylor Farms brand Fruit Medley 20 lb. tub, no product code, Recall # F-486-8;
38) Taylor Farms brand Fruit Mix in 10 oz Clamshell (product code 23114826101), 10 oz cup
       (product code 23114806071), and 7 oz cup (product code 23114806071), Recall # F-487-8;
39) Taylor Farms brand Fruit Mix With Grape Tray, 5 lb., Product code 68065802011, Recall # F-488-8;
40) Safeway brand Fruit Salad Kit in 10 lb tray, product code 68054661101, Recall # F-489-8;
41) Taylor Farms brand Fruit Salad Kit in 10 lb tray, product code 68054661101, Recall # F-490-8;
42) Taylor Farms brand Melon Mix in 7 oz. cups, product code 23104806071, Recall # F-491-8;
43) Taylor Farms brand Mixed Cut Fruit in 10 oz Clamshell container, Product Code 23114826101,
      Recall # F-492-8;
44) Royal Farms brand Mixed Fruit in 7 oz cups, product code 23114756071, Recall # F-493-8;
45) Royal Farms brand Mixed Melon in 7 oz cups, product code 23104756071, Recall # F-494-8;
46) Garden Highway brand Fruit Platter in 4-lb. cups and trays, 3 per case, SKU 10250386, Recall # F-495-8
CODE
1); 3); 5); 6); 7); 8); 9);  13); 15); 16); 17); 18); 19); 20); 21);  24);  Best if used by date of 03/23/2008;
2) 12 oz. - best if used by dates 03/23/2008 and 3-25; 24 oz. - 3-25;
4) Best if used by dates 3/22/2008-03/25/2008;
10) BIUB 03/24/2008;
11) BIUB dates of 03/23 and 25/2008 (12 oz.) and 03/22 (24 oz.);
12) BIUB date 03/25/2008;
14) BIUB 03/25/08 (5 lb.), 3/22/23/25 (12 oz.), 3/23 (24 oz.);
22) BIUB dates 3-23, 25, 26;
23) BIUB date 03/22, 03/25 (5 lb.), 3/25, 3/26 (10 lb.);
25) BIUB dates 03/29, 03/31, 04/02, 04/05;
26) BIUB dates 03/29, 03/31, 04/02, 04/03, 04/05; single tub case: 03/29,31, 04/05;
27) BIUB dates 03/29, 03/31, 04/02, 04/05 (tub only);
28) BIUB dates 03/29, 03/30;
29) Julian Date codes TFT075A, TFT077A, TFT080A, TFT082A; Julian date codes 67, 71, 78, 79, 80 (5-lb. tray only);
30) Julian Date code TFT075A;
31) BIUB date 04/03;
32) BIUB date 03/29; Julian date code 79, 3/27/2008 (20-lb. bucket);
33) Julian date codes 67, 71, 78, 79, 81, BIUB dates 3/15/2008, 3/19/2008, 3/26/2008, 3/27/2008, 3/29/2008;
34) Julian date code 67, BIUB date 3/15/2008;
35) Julian date code 81, BIUB date 3/29/2008;
36) Julian date codes 71, 78, 81;
37) Julian Date 79, BIUB date 03/27/2008;
38) Clamshell: Julian date 67, 81, BIUB date 3/15/2008, 3/29/2008; 10 oz cup: Julian date 79,
      BIUB date 03/27/2008; 7 oz cup Julian dates 67, 71, 78, 80, 81, BIUB dates 3/15, 19, 26, 28, 29/2008;
39) Julian date 78, BIUB date 3/26/2008;
40) Julian dates 67, 71, 78, 79, 80, 81, BIUB dates 3/17, 21, 28, 29, 30, 31/2008;
41) Julian date code 67, 71, BIUB dates 3/17, 19/2008;
42) Julian Date codes 67, 71, 78, BIUB dates 03/15, 19, 26/2008;
43) Julian Date 79, BIUB date 03/27/2008;
44) Julian Dates 67, 71, 78, 79, 81, BIUB dates 3/15, 19, 26, 27, 29/2008;
45) Julian Dates 67, 71, 78, 79, BIUB dates 3/15, 19, 26, 27/2008;
46) Best if used by dates 3/23/2008 and 3/24/2008
RECALLING FIRM/MANUFACTURER
Taylor Fresh Foods Inc, Salinas, CA, by letters on March 24, 2008 and by press release on April 3, 2008. Firm initiated recall is complete.
REASON
Product has been linked to an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
4666 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Post LiveActive for Digestive Health Cereal, Mixed Berry Crunch; whole grain flakes with lightly sweetened crunchy clusters, cranberries and blueberries; Net Wt 13 oz., 14 boxes per case; UPC 0 43000 02389 1 on box, UPC 00430000238900 on case, Recall # F-497-8
CODE
Best When Used By 17 DEC 08 M
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc., Northfield, IL, by press release on June 5, 2008.
Manufacturer: Kraft General Foods/Post Division, Modesto, CA. Firm initiated recall is ongoing.
REASON
A small number of the boxes of cereal may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label.
VOLUME OF PRODUCT IN COMMERCE
11,598 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Caseificio Voglia di Latte Burrata in white and green plastic wrapper, 8.8 oz, Recall # F-496-8
CODE
Lots: 24/5/2008, 31/5/2008, and 07/06/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresca Italia, Inc., Brisbane, CA, by press release, letters and e-mails on May 30, 2008 and by press release on June 23, 2008.
Manufacturer: Caseificio Voglia di latte srl, Bisceglie, Italy. Firm initiated recall is ongoing.
REASON
The product was found to be positive for Listeria monocytogenes by the California Department of Food and Agriculture.
VOLUME OF PRODUCT IN COMMERCE
275 kg
DISTRIBUTION
CA
___________________________________
PRODUCT 
a) Puffed Wheat cereal. Ingredients: Wheat, Ferric ortho-phosphate (iron),
   Niacin (niacinamide), vitamin B1 (thiamin mononitrate), vitamin B2 (riboflavin).
    Packaged under the following labels:
    1) Malt-O-Meal, Net Wt 6 oz UPC 042400002208, 12 oz UPC 042400200208, and
        16 oz UPC 042400002611. Made in U.S.A.;
    2) ACME, Net Wt. 6 oz UPC 075090877825;
    3) America's Choice, Net Wt 6 oz UPC 754807414897;
    4) Food Club, Net Wt 6 oz UPC 036800318533;   
    5) Giant, Net Wt 6 oz UPC 688267026911;
    6) Hannaford, Net Wt 6 oz UPC 041268108435;
    7) Jewel, Net Wt 6 oz UPC 041280054697;
     8) Laura Lynn, Net Wt 6 oz UPC 086854006221;
     9) Pathmark, Net Wt 6 oz UPC 041240124903- Made in USA.;
    10) Shaw's, Net Wt 6 oz UPC 045674132282;
    11) Shop Rite, Net Wt 6 oz UPC 041190009749. Made in U.S.A.;
    12) Tops, Net Wt 6 oz UPC 688267026911;
    13) Weis, Net Wt 6 oz UPC 041497529148, Recall # F-498-8;
b) Puffed Rice cereal. Ingredients: Rice, Ferric orthophosphate (iron), Niacin (niacinamide),
    vitamin B1 (thiamin mononitrate), vitamin B2 (riboflavin), wheat starch.
    Packaged under the following labels:
    1) Malt-O-Meal, Net Wt 6 oz UPC 042400002406, 12 oz UPC 042400200215,
        and 16 oz UPC 042400002703. Made in U.S.A.;
    2) ACME, Net Wt. 6 oz UPC 075090877832;
    3) Food Club, Net Wt 6 oz UPC 036800318526;
    4) Giant, Net Wt 6 oz UPC 688267026904;
    5) Hannaford, Net Wt 6 oz UPC 041268108442;
    6) Jewel, Net Wt 6 oz UPC 041280054680;
    7) Laura Lynn, Net Wt 6 oz UPC 086854006238;
   8) Pathmark, Net Wt 6 oz UPC 041240124910- Made in USA;
   9) Shaw's, Net Wt 6 oz UPC 045674132190;
   10) Shop Rite, Net Wt 6 oz UPC 041190009756. Made in U.S.A.;
   11) Tops, Net Wt 6 oz UPC 688267026904;
   12) Weis, Net Wt 6 oz UPC 041497529162, Recall # F-499-8
CODE
All lot codes with "Best if Used By" dates between APR0808 (April 8, 2008) and MAR1809 (March 18, 2009).
RECALLING FIRM/MANUFACTURER
Malt O Meal Company, Northfield, MN, by press release and e-mail beginning on April 5, 2008. Firm initiated recall is ongoing.
REASON
Products have been associated with an outbreak of Salmonella Agona infections.
VOLUME OF PRODUCT IN COMMERCE
248,809 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
a) 100% Pear Juice from concentrate with Vitamin C
a) Beech-Nut Naturals Gentle Juice brand, 4 Fl. oz. (118 mL), 12 count pack,
    Jar UPC 0-523202-6, Retail Unit UPC 0-523202-6;
    b) Beech-Nut brand Net Wt. 32 Fl oz (1 qt) 946 mL, 12 pack --- Jar UPC 0-523312-2,
        Retail Unit UPC 0-523312-2, Recall # F-439-8;
b) Gentle Juice Variety Pack - Apple, White Grape, Pear - Beech-Nut Naturals
    Gentle Juice 100% Juice from concentrate with Vitamin C, Four 4 Fl. oz.
    Bottles, 16 FL. OZ. (473 mL), 4 oz. 4 pack variety pack (1 pear juice per pack,
    6 to a case), Jar UPC 0-523202-6, Retail Unit UPC 0-523022-2, Recall # F-440-8
CODE
a) a) Cap Code 71 22 JAN09 C0320xxxxx, Variety Code 02320,
    b) Cap Code 81 08APR09 P0331xxxxx, Variety Code 00331;
b) Cap Code 71 22 JAN09 C0320xxxxx, Variety Code 00302
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beech-Nut Nutrition Corp. Latham, NY, by letter and telephone on May 14/15, 2008.
Manufacturer: Beech-Nut Nutrition Corporation, Canajoharie, NY. Firm initiated recall is ongoing.
REASON
Pear Juice contained elevated level of arsenic.
VOLUME OF PRODUCT IN COMMERCE
2,804 cases of 24 count; 1,775 cases of 12 count
DISTRIBUTION
Nationwide, PR, England, South Africa, Nassau-Bahamas
___________________________________
PRODUCT 
Knott's (Old Fashioned) Jalapeno Pimiento Cheese Spread, Net wt 12 oz (340g), Recall # F-443-8
CODE
Lot code: 28 AUG 08
RECALLING FIRM/MANUFACTURER
Knotts Wholesale Foods Inc., Paris, TN, by contacting route men on July 19, 2008. Firm initiated recall is ongoing.
REASON
Metal fragments were found in the product.
VOLUME OF PRODUCT IN COMMERCE
240 units
DISTRIBUTION
TN and KY
___________________________________
PRODUCT 
Jerusalem brand pita bread, spelt wheat free, 6 loaves, net wt. 16 oz., Recall # F-444-8
CODE
All lots
RECALLING FIRM/MANUFACTURER
Jerusalem Manufacturing Natural Foods & Wholesalers, Inc., by telephone, fax and letter on March 18, 2008. Firm initiated recall is ongoing.
REASON
Undeclared wheat; the label states wheat-free, but spelt is a form of wheat
VOLUME OF PRODUCT IN COMMERCE
6708 loaves
DISTRIBUTION
IL, IN, IA, MI and OH
___________________________________
PRODUCT 
Astro Pop, frozen confection, sold under the following brands - SSI Missle, Valutime, Rainbow Glacier, Albertson's, and Vitafreze, Recall # F-445-8
CODE
Code dates 1539 - JUN 02-09 1549 - JUN 02-09 1559 - JUN 03-09 1569 - JUN 04-09 1579 - JUN 05-09
RECALLING FIRM/MANUFACTURER
Vitafreze Frozen Confections, Sacramento, CA, by e-mail and telephone on June 10, 2008. Firm initiated recall is ongoing.
REASON
Products may contain plastic fragments.
VOLUME OF PRODUCT IN COMMERCE
2862 cases
DISTRIBUTION
AZ and CA
___________________________________
PRODUCT 
Ross Metabolics brand Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron; powdered formula in 14.1 oz.(400 g) size cans, Recall # F-500-8
CODE
Lot #: 39973RB & Lot #: 47239RB6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Nutrition Columbus Plant Abbott Laboratories, Columbus OH, by letters on May 30, 2008.
Manufacturer: Abbott Laboratories, Inc., Sturgis, MI. Firm initiated recall is ongoing.
REASON
Air may enter the container resulting in oxidation of the formula.
VOLUME OF PRODUCT IN COMMERCE
13,356 units
DISTRIBUTION
Nationwide, Canada, Korea, Malaysia and Bahrain

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT 
Walnut Nuggets; Net 9 oz. (255.60g) cello pack, UPC 7 90429 21375 3, Recall # F-442-8
CODE
Lot # 21724, Best By 5/7/08 and 5/8/08
RECALLING FIRM/MANUFACTURER
International Foodsource, LLC, Dover, NJ, by letters on or about October 5, 2007. Firm initiated recall is complete.
REASON
Product is contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
22,784 bags
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Nifediac CC (Nifedipine) Extended-release Tablets USP, 90 mg, 100-tablet bottles, Rx only, NDC 0093-1023-01, Recall # D-241-2008
CODE
Lot: 0703T33, exp. 2/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, by letters on June 18, 2008.
Manufacturer: Biovail Corporation, Steinbach Manitoba, Canada. Firm initiated recall is ongoing.
REASON
Product does not meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
9,240 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Fresh Frozen Plasma (Apheresis), Recall # B-1426-08
CODE
Units: 18P76675 ,18P76673
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on July 20, 2007 and letter on July 24, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to current Good Manufacturing Practices, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1495-08;
b) Recovered Plasma, Recall # B-1496-08
CODE
a) and b) Unit: 17FR32006
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by letter and e-mail on July 13, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported a history of hospitalization for an enlarged liver, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI, IL
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-1584-08;
b) Platelets, Recall # B-1585-08
CODE
a) Units: FK55863, KC68131;
b) Units: FK16571, GC35681
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and facsimile on December 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the Human Immunodeficiency Virus (HIV), but were collected from a donor who was previously deferred for testing positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, NY, MI
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1608-08
CODE
Unit: 9864388
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on June 7, 2007 and by letter dated June 12, 2007. Firm initiated recall is complete.
REASON
Blood product, with a platelet count that exceeded the firm’s specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1609-08
CODE
Unit: 9944772
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 18, 2006 and by letter dated August 21, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
a) Fresh Frozen Plasma, Recall # B-1610-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1611-08
CODE
a) and b) Units: 368532386
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank dba UBS Central Coast, Ventura, CA, by telephone on February 17, 2006 or by letter dated March 27, 2006. 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
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma, Recall # B-1612-08
CODE
Units: DQ038420, DQ038169
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1613-08
CODE
Units: DQ039103, DQ038774, DQ038358, DQ038155
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1614-08
CODE
Unit: DQ039664
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1615-08
CODE
Units: DQ039900, DQ039691
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1617-08
CODE
Units: DQ039839, DQ039339, DQ038647, DQ038056, DQ037904
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1618-08
CODE
Unit: DQ039507
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1619-08
CODE
Unit: DQ039832
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1620-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1621-08
CODE
a) and b) Unit: 110026103
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, El Paso, TX, by telephone on August 24, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, NM
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1622-08
CODE
Unit: 3733821
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 7, 2007. Firm initiated recall is complete.
REASON
Blood product, which was hemolyzed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1625-08
CODE
Unit: 30GV35210
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by fax on April 21, 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
NY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1628-08
CODE
Unit: 30FW33205
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by fax on April 22, 2008. Firm initiated recall is complete.
REASON
Donor Screening/Donor record incomplete or incorrect.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1630-08
CODE
Unit: 158328880
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Lubbock Center, Lubbock, TX, by telephone on January 4, 2007. Firm initiated recall is complete.
REASON
Blood product, with a Total High and Percent Target RBC volume below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM

___________________________________
PRODUCT 
a) Fresh Frozen Plasma, Recall # B-1631-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1632-08
CODE
a) and b) Unit: 362711384
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank dba UBS Central Coast, Ventura, CA, by letter dated January 30, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1636-08;
b) Cryoprecipitated AHF, Recall # B-1637-08;
c) Fresh Frozen Plasma, Recall # B-1639-08
CODE
a) Units: 22GL41472, 22GJ03528;
b) Unit: 22GL41472;
c) Unit: 22GJ03528
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on February 27, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
PA, NJ, CA
___________________________________
PRODUCT 
OBSERVA® Software/Version R01.00.16, R02.00.17 and R02.01.05, Recall # B-1649-08
CODE
Software/Version R01.00.16, R02.00.17 and R02.01.05
RECALLING FIRM/MANUFACTURER
BioMerieux, Inc., Durham, NC, by letter on/about August 3, 2007. Firm initiated recall is complete.
REASON
Bacterial Detection Software with some error conditions that may cause a delay in reporting positive cultures to the laboratory information management system (LIS), was distributed.
VOLUME OF PRODUCT IN COMMERCE
10,790 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1660-08
CODE
Unit: 5336249
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by electronic mail and facsimile on June 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria and FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1661-08
CODE
Unit: 4285062
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., St Petersburg, FL, by facsimile on December 26, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm scrub procedure was performed incorrectly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1663-08
CODE
Units: 4475646 Part 1; 4475646 Part 2 ;4462976 Part 1; 4462976 Part 2; 4475726 Part 1; 4475726 Part 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., St Petersburg, FL, by telephone on November 4, 2005. Firm initiated recall is complete.
REASON
Blood products, collected using apheresis kits with small detected leaks, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1591-08;
b) Recovered Plasma, Recall # B-1592-08
CODE
a) and b) Unit: 9215085
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone and electronic mail on August 6, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, Switzerland
___________________________________
PRODUCT 
a) Recovered Plasma, Recall # B-1593-08;
b) Red Blood Cells, Recall # B-1594-08;
c) Platelets, Recall # B-1595-08
CODE
a), b) and c) Unit: W74208
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by facsimile and electronic mail on February 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI, Switzerland
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1598-08
CODE
Unit: 18X77653
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on June 26, 2006 and by letter on July 3, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an invalid result for body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Recovered Plasma Frozen, Recall # B-1626-08
CODE
Unit: 30GV35210
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by the LOGIC System on April 21, 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
NY
___________________________________
PRODUCT 
Recovered Plasma Frozen, Recall # B-1627-08
CODE
Unit: 30FW33205
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by the LOGIC System on April 22, 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
PA
___________________________________
PRODUCT 
Recovered Plasma Frozen, Recall # B-1629-08
CODE
Unit: 027GY95280
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by e-mail on April 18, 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 
Plasma Frozen Cryoprecipitated Reduced, Recall # B-1638-08
CODE
Unit: 22GL41472
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on February 27, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA, NJ, CA
___________________________________
PRODUCT 
a) DBM 3.75CC. Bone tissue for further processing, Recall # B-1724-08;
b) DBM 6 CC, Recall #  B-1725-08;  
c) For Further Processing (FFP)- CORTICAL (125-850UM), Recall #  B-1726-08; 
d) For Further Processing (FFP) - CORTICAL DEMIN (125-500UM), Recall #  B-1727-08;
e) For Further Processing (FFP) - CORTICAL DEMIN (125-850UM), Recall #  B-1728-08
CODE
a) Deposit #: ADB9651008107 ADB9651008407 ADB9651008607 ADB9651008707 ADB9651003807 ADB9651003907 ADB9651004007 ADB9651004107 ADB9651004207 ADB9651004307 ADB9651004407 ADB9651004507 ADB9651004607 ADB9651004707 ADB9651004807 ADB9651004907 ADB9651005007 ADB9651005107 ADB9651005207 ADB9651005307 ADB9651005407 ADB9651005507 ADB9651005607 ADB9651005707 ADB9651005807 ADB9651005907 ADB9651006007 ADB9651006107 ADB9651006207 ADB9651006307 ADB9651006407 ADB9651006507 ADB9651006607 ADB9651006707 ADB9651006807 ADB9651006907 ADB9651007007 ADB9651007107 ADB9651007207 ADB9651007307 ADB9651007407 ADB9651007507 ADB9651007607 ADB9651007707 ADB9651007807 ADB9651007907 ADB9651008007 ADB9651008207 ADB9651008307 ADB9651008507;
b) Deposit Number: ADB8039003506 ADB8039003606 ADB8039003706 ADB8039003806 ADB8039003906 ADB8039004006 ADB8039004106 ADB8039004206 ADB8039004306 ADB8039004406 ADB8039004506 ADB8039004606 ADB8039004706 ADB8039004806 ADB8039004906 ADB8039005006 ADB8039005106 ADB8039005206 ADB8039005306 ADB8039005406 ADB8039005506 ADB8039005606 ADB8039005706 ADB8039005806 ADB8039005906 ADB8039006006 ADB8039006106 ADB8039006206 ADB8039006306 ADB8039006406 ADB8039006506 ADB8039006606 ADB8039006706 ADB8039006806 ADB8039006906 ADB8039007006 ADB8039007106 ADB8039007206 ADB8039007306 ADB8039007406 ADB8629001907 ADB8629002007 ADB8629002107 ADB8629002207 ADB8629002307 ADB8629002407 ADB8629002507 ADB8629002607 ADB8629002707 ADB8629002807 ADB8629002907 ADB8629003007 ADB8629003107 ADB8629003207 ADB8629003307 ADB8629003407 ADB8629003507 ADB8629003607 ADB8629003707 ADB8629003807 ADB8629003907 ADB8629004007 ADB8629004107 ADB8629004207 ADB8629004307 ADB8629004407 ADB8629004507 ADB8629004607 ADB9670005007 ADB9670005207 ADB9670005307 ADB9670005407 ADB9670005607 ADB9670005807 ADB9670006107 ADB9670006307 ADB9670009007 ADB9670010007 ADB9670010107 ADB9670010207 ADB9670010307 ADB9670010407 ADB9670010607 ADB9670010707 ADB9670004807 ADB9670004907 ADB9670005107 ADB9670005507 ADB9670005707 ADB9670005907 ADB9670006007 ADB9670006207 ADB9670006407 ADB9670006507 ADB9670006607 ADB9670006707 ADB9670006807 ADB9670006907 ADB9670007007 ADB9670007107 ADB9670007207 ADB9670007307 ADB9670007407 ADB9670007507 ADB9670007607 ADB9670007707 ADB9670007807 ADB9670007907 ADB9670008007 ADB9670008107 ADB9670008207 ADB9670008307 ADB9670008407 ADB9670008507 ADB9670008607 ADB9670008707 ADB9670008807 ADB9670008907 ADB9670009107 ADB9670009207 ADB9670009307 ADB9670009407 ADB9670009507 ADB9670009607 ADB9670009707 ADB9670009807 ADB9670009907 ADB9670010507 ADB9074001807 ADB9074001907 ADB9074002007 ADB9074002107 ADB9074002207 ADB9074002307 ADB9074002407 ADB9074002507 ADB9074002607 ADB9074002707 ADB9074002807 ADB9074002907 ADB9074003007 ADB9074003107 ADB9074003207 ADB9074003307 ADB9074003407 ADB9074003507 ADB9074003607 ADB9074003707 ADB9074003807 ADB9074003907 ADB9074004007 ADB9074004107 ADB9074004207;
c) Deposit # ABA7814000204;
d) Deposit #: ADBB095000107 ADBA665000107;
e) Deposit #: ABA7679000204 ADB7922000104 ADB7958000204 ADB7994000204 ADB7998000104 ADB8050000304 ADB8147000204 ADB8149000204 ADB8166000204 ADB8194000204 ADB8213000104 ADB8239000204 ADB8249000204 ADB8280000204 ADB8287000204 ADB8293000104 ADB8319000104 ADB8327000104 ADB8366000104 ADB8478000205 ADB8564000205 ADB8940000205 ADB9007000205 ADB9036000205 ADB9059000205 ADB9189000305 ADB9277000105 ADB9367000105 ADB9387000105 ADB9416000205 ADB9418000105 ADB9499000205 ADB9532000205 ADB9543000205 ADB9571000305 ADB9585000205 ADB9677000106 ADB9921000206
RECALLING FIRM/MANUFACTURER
Lifelink Foundation Tissue Bank, Tampa, FL, by letter and telephone on November 27, 2007. Firm initiated recall is complete.
REASON
Donor samples were retested for Hepatitis B surface antigen and Anti-HBcore due to the discovery that the original test kits used were diagnostic kits instead of FDA licensed or cleared donor screening kits. Samples from all donors retested negative for Hepatitis B surface antigen and Hepatitis B core total antibody negative.
VOLUME OF PRODUCT IN COMMERCE
244
DISTRIBUTION
CA, NJ

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT 
BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board, Recall # Z-1233-2008
CODE
There are no serial numbers on the BHM Medical Infrared (IR) Hand Control System, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board. The hand controls were installed on the following ceiling lifts: i) Maxi Sky 600, part LD10111, serial numbers LD-2605-15164, LD30733967, LD30733968, LD480627315, LD-5105-21404; ii) V4, part 9100021, serial numbers V4-1107-29534, V4-1307-29837, V4-3307-33778, V4-1507-30147, V4-1905-14715, V4-4205-18404, V4-3606-26259, LD-1706-24108, V4-0206-22026, V4-3405-16157, V4-4606-27188, V4-4803-04671, V4-1307-29838, V4-1806-24149, V4-3307-33779, V4-4207-36144; part 9100021.13, serial numbers V4-0805-09557, V4-1006-23261; part 9100023, serial number V4-1406-23773; and part 9101021, serial number V4-0105-08044
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated February 15, 2008.
Manufacturer: B. H. M. Medical, Inc., Magog, Canada. Firm initiated recall is ongoing.
REASON
The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a ceiling lift equipped with an infrared hand control.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System, Recall # Z-1235-2008
CODE
Lot Numbers: 527059 and 527061
RECALLING FIRM/MANUFACTURER
American Medical Systems, Minnetonka, MN, by telephone and letters dated January 28, 2008. Firm initiated recall is ongoing.
REASON
Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Recall # Z-1315-2008
CODE
Serial Numbers: ARWM0008, ARWM0009, ARWM0010, ARWM0011, ARWM0012, ARWM0013, ARWM0014, ARWM0015, ARWM0029, ARWM0030, ARWM0031, ARWM0032, ARWM0033, ARWM0034, ARWM0035, ARWM0036, ARWM0037, ARWM0050, ARWM0051, ARWM0052, ARWM0053, ARWM0057, ARWM0058, ARWM0059, ARWM0061, ARWM0062, ARWM0063, ARWM0064, ARWM0065, ARWM0066, ARWM0067, ARWM0068, ARWM0069, ARWM0070, ARWM0071, ARWM0072, ARWM0073, ARWM0074, ARWM0075, ARWM0076, ARWM0077, ARWM0078, ARWM0079, ARWM0080, ARWM0081, ARWM0082, ARWM0083, ARWM0084, ARWM0085, ARWM0092, ARWM0093, ARWM0097, ARWM0098, ARWM0099, ARWM0100, ARWM0101, ARWM0102, ARWM0103, ARWM0104, ARWM0105, ARWM0108, ARWM0112, ARWM0113, ARWM0114, ARWM0115, ARWM0116, ARWM0117, ARWM0118, ARWM0119, ARWM0120, ARWM0121, ARWM0122, ARWM0123, ARWM0124, ARWM0125, ARWM0126, ARWM0127, ARWM0128, ARWM0129, ARWM0130, ARWM0131, ARWM0132, ARWM0133, ARWM0134, ARWM0135, ARWM0136, ARWM0137, ARWM0138, ARWM0139, ARWM0140, ARWM0157, ARWM0159, ARWM0160, ARWM0161, ARWM0162, ARWM0163, ARWM0164, ARWM0165, ARWM0167, ARWM0168, ARWM0169, ARWM0170, ARWM0171, ARWM0172, ARWM0176, ARWM0177, ARWM0178, ARWM0179, ARWM0180, ARWM0181, ARWM0184, ARWM0215, ARWM0216, ARWM0217, ARWM0219, ARWM0224, ARWM0232, ARWM0284, ARWM0285, ARWM0286, ARWM0287, ARWM0288, ARWM0289, ARWM0308, ARWM0309, ARWM0310, ARWM0311, ARWM0313, ARWM0314, ARWM0315, ARWM0323, ARWM0326, ARWM0327, ARWM0328, ARWM0329, ARWM0330, ARWM0331, ARWM0333, ARWM0335, ARWM0337, ARWN0001, ARWN0002, ARWN0003, ARWN0005, ARWN0014, ARWN0015, ARWN0016, ARWN0017, ARWN0018, ARWN0019, ARWN0022, ARWN0023, ARWN0024, ARWN0025, ARWN0026, ARWN0027, ARWN0028, ARWN0029, ARWN0030, ARWN0031, ARWN0033, ARWN0034, ARWN0035, ARWN0036, ARWN0037, ARWN0038, ARWN0039, ARWN0040, ARWN0041, ARWN0042, ARWN0043, ARWN0044, ARWN0045, ARWN0046, ARWN0058, ARWN0060, ARWN0061, ARWN0062, ARWN0063, ARWN0064, ARWN0065, ARWN0066, ARWN0067, ARWN0076, ARWN0078, ARWN0080, ARWN0081, ARWN0082, ARWN0083, ARWN0084, ARWN0085, ARWN0087, ARWN0088, ARWN0176, ARWN0184, and ARWN0214
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter on February 7, 2008.
Manufacturer: Draeger Medical AG & Co, Lubeck, Germany. Firm initiated recall is ongoing.
REASON
Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.
VOLUME OF PRODUCT IN COMMERCE
196 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory
    pressure breathing attachment; Reference Number: P60000; Recall # Z-1379-2008;
b) Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure
    breathing attachment; Reference Number: P63000; Recall # Z-1380-2008
CODE
a) Lot Numbers: 37L04D188 and 38A030257;
b) Lot Numbers: 38A30D064 and 38B09D021
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical ASD, Inc., Rockland, MA, by telephone on February 26, 2008 and by letter on March 4, 2008.
Manufacturer: Smiths Medical ASD, Inc., Dublin, OH. Firm initiated recall is ongoing.
REASON
Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.
VOLUME OF PRODUCT IN COMMERCE
846 eaches
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices, Recall # Z-1917-2008
CODE
Lot #’s: HL-31707, HL-31807, HL-32708, HL-32808 & HL-32908
RECALLING FIRM/MANUFACTURER
Celsus Laboratories, Inc., Cincinnati, OH, by e-mail on April 24, 2008. Firm initiated recall is ongoing.
REASON
Contamination: The firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier.
VOLUME OF PRODUCT IN COMMERCE
HL-31707=11,542g, HL-31807=12,836g, HL-32708=8,374g, HL-32808=12,128g & HL-32908=5,000g
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model number: 8596SC; Packaged with catheter model number 8731 or 8731SC. Recall # Z-1308-2008
CODE
Lot Numbers: N131154001, N131154003, N131154004, N131154008, N131154009, N131154010, N131154013, N131154016, N131154017, N130483001, N130483004, N130483006, N130483011, N130483012, N130483013, N130483014, N130483015 and N130483021
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, by letter on January 2008. Firm initiated recall is ongoing.
REASON
Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10, Recall # Z-1372-2008
CODE
Lot Number: 172010207
RECALLING FIRM/MANUFACTURER
Recalling Firm: OEC Medical Systems, Inc., Salt Lake City, UT, by letter on December 20, 2007.
Manufacturer: Contour Fabricators Inc., Fenton MI. Firm initiated recall is ongoing.
REASON
No Premarket Notification: Product does not have FDA 510(k) approval for use.
VOLUME OF PRODUCT IN COMMERCE
158 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass, Recall # Z-1479-2008
CODE
Part Numbers: 3300-0001-PL and 3300-0002-PL
RECALLING FIRM/MANUFACTURER
Abbott Spine, Austin, TX, by telephone on February 13, 2008 and by letter on February 20, 2008. Firm initiated recall is ongoing.
REASON
Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)
VOLUME OF PRODUCT IN COMMERCE
38 kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT 
a) Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial
    polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R;
    Recall # Z-1381-2008;
b) Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial
    polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R;
    Recall # Z-1382-2008
CODE
a) Lot Number: K04W966;
b) Lot Number: K04W718
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on February 8, 2005. Firm initiated recall is complete.
REASON
Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS III

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PRODUCT 
a) Country Acres Horse Sweet 10, 50 lb bags, Recall # V-212-2008;
b) Country Acres Horse Pellet 12, Net Weight 50 lbs (22.68 kg),
    Recall # V-213-2008;
c) Purina Equine Senior, Recall # V-214-2008;
d) Horse Chow #100, Recall # V-215-2008
CODE
a) Lot’s: 7NOV17STA, 7NOV29STA, 8JAN05STA, 8JAN14STA, 8JAN15STA,
    8JAN19STA, 8JAN25STA and 8JAN28STA;
b) Lot: 8JAN11STA;
c) Lot’s:  8FEB01STA and 8FEB08STA;
d) Lot 7NOV03STA
RECALLING FIRM/MANUFACTURER
Land O’Lakes Purina Feed LLC, Statesville, NC, by letter on February 14, 2008``. Firm initiated recall is ongoing.
REASON
Product was found to contain aflatoxin above acceptable levels.
VOLUME OF PRODUCT IN COMMERCE
13,522/50 lb bags
DISTRIBUTION
NC, SC, VA and WV
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PRODUCT 
a) Dr. Turtle Medication Block Card - Item No. 35440, Recall # V-223-2008;
b) Dr. Turtle Medication Block Bulk - Item No. 35470, Recall # V-224-2008
CODE
a) Lot numbers: 964403 DA; 126444 DB; 174401 DC; 374402 DD; 474403 DE; 674404 DF;
    117545 DO; 1 17546 DH; 284501 DI; 485502 DJ;
b) Lot numbers: 964403 DA; 126444 DB; fl4401 DC; 374402 DD; 474403 DE; 674404 DF;
    1 17545 DO; 1 17546 DH; 284501 DI; 485502 DJ
RECALLING FIRM/MANUFACTURER
Aquatrol Inc., Anaheim, CA, by telephone on May 16, 2008 and letter beginning on June 5, 2008. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to product mislabeling, in that; the product may not contain the specified level of the sulfathiazole ingredient.
VOLUME OF PRODUCT IN COMMERCE
154,313 units
DISTRIBUTION
Nationwide and Guam

END OF ENFORCEMENT REPORT FOR JULY 23, 2008

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