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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.
September 19 , 2007
07-38
___________________________________
PRODUCT
Ultra Egg White Protein Powdered Drink Mix, Vanilla, Chocolate and Strawberry flavors, manufactured under the brand names: Vitalabs, Jay Robb’s, Bellissima, Body By Todd, Classic Anatomy-Gym Mix A Meal, Coad, Desert Burn, Fitness Systems, Desert Burn, Fitness Systems, Hannon Health Systems Albumin Isolate, Lanny’s Albumin Isolate, Len Rossi, Miracle II Now, NCP Miracle, Inc., Apple A Day, Mother Nature’s Market, Nutrition World, Return to Eden, and Olympia Egg Protein. Containers are produced in 1, 2, and 6 pound plastic jugs and 4' x 5' silver single serving packets, net weight 30 grams, Recall # F-508-7
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Vitalabs, Inc., Jonesboro, GA, by press release on January 29, 2007, and by telephone and letter on January 31, 2007. Firm initiated recall is complete.
REASON
Product may contain undeclared milk protein.
VOLUME OF PRODUCT IN COMMERCE
471,991 lbs.
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II
___________________________________
PRODUCT
Cilantro Chef brand Chile from Chile Sauce, packed in 350 gram plastic bottles distributed 24 bottles per case, Recall # F-509-7
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cilantro Trading International L, Kettering, OH, by telephone on June 21, 2007 and by visit between June 22, 2007, and July 1, 2007.
Manufacturer: Traverso, Santiago, Chile. Firm initiated recall is ongoing.
REASON
Product contains an unapproved color additive, sunset yellow FCF, which is certifiable as FD&C Yellow No. 6.
VOLUME OF PRODUCT IN COMMERCE
602 bottles (25 cases)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
A) Whole Wheat Bread; freshly baked bread packaged in poly-film plastic bags under the following labels:
a) Sara Lee Hearty & Delicious 100% Whole Wheat Bakery Bread, Net Wt 24 oz,
Sara Lee Food & Beverage, UPC 0 72945 60157 4;
b) Sara Lee Fresh Ideas Deli Style 100% Whole Wheat Bread Thick Sliced, Net Wt 24
oz, Sara Lee Food & Beverage, UPC 0 72945 61001 9;
c) EarthGrains 100% Natural Whole Wheat 100% Stone Ground Bakery Bread, Net Wt
24 oz, EarthGrains Baking Companies, Inc., UPC 0 50400 72746 5;
d) Grissom's Home Baked Goodness Wheat Bread, Net Wt 20 oz, Distributed by:
Save-A-Lot Food Stores, Ltd., UPC 0 51933 26710 7;
e) Great Value Wheat Sandwich Bread, Net Wt 24 oz, Marketed by Wal-Mart Stores,
Inc., UPC 0 78742 28543 6;
f) IGA Wheat Bread, Net Wt 20 oz, Distributed by IGA, Inc., UPC 0 41270 03695 5;
g) Piggly Wiggly Wheat Bread, Net Wt 20 oz, Distributed by Piggly Wiggly LLC,
UPC 0 41290 01118 5;
h) Great Value Split Top Wheat Bread, Net Wt 20 oz, Marketed by Wal-Mart Stores,
Inc., UPC 0 78742 06274 7;
i) Shurfresh Split Top Wheat Enriched Bread, Net Wt 20 oz, Distributed by Topco
Associates LLC, UPC 0 11161 44835 8;
j) Publix Premium 100% Stone Ground Whole Wheat Bread, Net Wt 20 oz,
Distributed by Publix Super Markets, Inc., UPC 0 41415 39190 1;
k) Sara Lee Hearty & Delicious 100% Whole Wheat with Honey Bakery Bread,
Net Wt 24 oz, Sara Lee Food & Beverage, UPC 0 72945 60152 9;
l) EarthGrains 100% Natural Wheat Berry with Honey Bakery Bread, Net Wt 24 oz,
EarthGrains Baking Companies, Inc., UPC 0 50400 72748 9;
m) Publix Premium Honey Wheat Bread, Net Wt 20 oz, Distributed by Publix Super
Markets, UPC 0 41415 39095 9;
n) Colonial Premium Wheat Sandwich Bread, Net Wt 20 oz, Sara Lee Bakery Group,
Inc., UPC 0 50400 23502 1;
o) Flavorite Sandwich Wheat Bread, Net Wt 20 oz, Distributed by Supervalu Inc.,
UPC 0 41130 02364 4;
p) Foodland Wheat Bread, Net Wt 20 oz, Distributed by Preferred Products, Inc,
UPC 0 41130 36619 2;
q) Publix Premium Wheat Bread, Net Wt 20 oz, Distributed by Publix Super Markets,
UPC 0 41415 39290 8;
r) Publix Premium Thin Sliced Stone Ground Wheat Bread, Net Wt 20 oz,
Distributed by Publix Super Markets, Inc., UPC 0 41415 39390 5;
s) Golden Bake Wheat Bread, Net Wt 20 oz, Sara Lee Bakery Group, Inc.,
UPC 0 50400 08505 3;
t) Grissom’s Home Baked Goodness Wheat Sandwich Bread, Net Wt 24 oz,
Distributed by: Moran Foods, Inc., UPC 0 51933 70300 1;
u) Schnucks Wheat Sandwich Bread, Net Wt 24 oz, Baked and Packaged for Schnuck
Markets, Inc.,
v) Sara Lee Delightful Wheat Bakery Bread, Net Wt 20 oz, Sara Lee Bakery
Group, Inc., UPC 0 72945 71706 0;
w) Sara Lee Delightful 100% Whole Wheat with Honey Bakery Bread,
Net Wt 20 oz, Sara Lee Bakery Group, Inc., UPC 0 72945 71589 9;
x) EarthGrains Honey Wheat Berry Bread, Net Wt 24 oz, Sara Lee Food &
Beverage, a UPC 0 50400 72709 0, Recall # F-510-7;
B) Multi-Grain Bread; freshly baked bread packaged in poly-film plastic bags
under the following labels:
a) Sara Lee Hearty & Delicious 100% Multi-Grain Bakery Bread, Net Wt 24 oz,
Sara Lee Food & Beverage, UPC 0 72945 60158 1;
b) Sara Lee Delightful 100% Multi-Grain Bakery Bread, Net Wt 20 oz, Sara Lee
Bakery Group, Inc., UPC 0 72945 71588 2 0;
c) EarthGrains 100% Natural 7-Grain Bakery Bread, Net Wt 24 oz,
EarthGrains Baking Companies, Inc., UPC 0 50400 72747 2,
Recall # F-511-7
CODE
Best If Purchased By JUL 25 07 222 through AUG 7 07 222
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sara Lee Food and Beverage, Downers Grove, IL, by e-mail on July 25, 2007 and by press release and telephone on July 26, 2007 followed by electronic notification.
Manufacturer: Sara Lee Bakery Group, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
The bread products may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
286, 478 loaves
DISTRIBUTION
MS, AL, AK, MO, GA, TN, LA, and FL
___________________________________
PRODUCT
King Henry’s Yogurt Pretzels; 2.5 oz aka $0.99 size, 6bag/case, UPC#35126; 6.5 oz aka $1.99 size, 12 bags/case, UPC#45182; 6.5 oz aka King Size, 12 bags/case, UCP# 45482 (Products in clear plastic bags with green product labels), Recall # F-513-7
CODE
Lot numbers stamped on product with manufacturing date ending with the last 6 digits: 070115, 070216, 070315, 070316, 070404, 070415, 070418, 070508, 070706
RECALLING FIRM/MANUFACTURER
King Henry’s Inc., Valencia, CA, by telephone and letters on July 9, 2007. Firm initiated recall is ongoing.
REASON
Product contains undeclared soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
4,847 cases
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Calcium Chews, Chocolate Flavored, Containing 500 mg Calcium, 100 IU Vitamin D, 400 mcg Vitamin K, Dietary Supplement under the Albertsons, Brooks, McKesson, Meijer, Rite Aid, Topco and Walgreen's Labels, Packed 60 chews to each canister, Recall # F-514-7
CODE
Lot Numbers: H0607, H0607A, H0607B, H0617, H0967
RECALLING FIRM/MANUFACTURER
NutraMax Products Inc., Gloucester, MA, by letter dated May 31, 2007. Firm initiated recall is ongoing.
REASON
Product contains undeclared soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
4,887 cases X 12 canisters per case
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III
___________________________________
PRODUCT
Unit box: Pathmark Diabetic Nutritional Shake, balanced nutrition for diabetics, strawberry, Naturally and Artificially flavored. The product is packaged in a carton containing 6 cans, 8 fl oz. each can.
Carton: Pathmark Pediatric Drink, strawberry balanced nutrition, Naturally and Artificially flavored. The product is sold in 8 fl. oz. cans, 6 cans per carton, UPC # 0-41240-20021, Recall # F-512-7
CODE
MAR1808 04S/ CT 267 XX:XX. This CODE is located on the box and can. UnCODEd boxes are also included.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pathmark Stores, Inc., Carteret, NJ, by e-mail and telephone on August 1, 2007.
Manufacturer: O-AT-KA Milk Products Cooperative, Inc., Batavia, NY. Firm initiated recall is ongoing.
REASON
Cartons labeled Diabetic Nutritional Shake contained another product, Pediatric Drink.
VOLUME OF PRODUCT IN COMMERCE
3,120 cans (130 trays)
DISTRIBUTION
NY, NJ, PA, and DE
___________________________________
PRODUCT
Fluoride Toothpaste, AmerFresh and Pacific labels, packaged in whicte opaque or clear plastic tubes, labeled ingredients include odium monofluorophosphate. Sold in three varieties: white paste, clear gel and red gel; container sizes: 0.6 oz, 0.85 oz, 1.5 oz, 2.75 oz, 3 oz and 3 grams. Sold separately or in hygiene kits. Made in China. Recall # D-973-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Phoenix Trading, Inc., Woodinville, WA, by letters on July 10, 2007. Firm initiated recall is ongoing.
REASON
Toothpaste from China contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
1,257,701 tubes various sizes; 262,493 kits with toothpaste
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
DentFresh Fluoride Toothpaste, Mint Flavor, 9 oz tubes, labeled ingredients include Sodium Monofluorophosphate and Glycerin. Made in China. Recall # D-974-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dent Fresh USA, Inc., Miami, FL, by press release on July 13, 2007 and letter on July 17, 2007.
Manufacturer: Suzhou City Jinmaco Daily Chemicals Co. Firm initiated recall is ongoing.
REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
126,000 tubes
DISTRIBUTION
FL and Haiti
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1357-07;
b) Cryoprecipitated AHF, Recall # B-1358-07;
c) Plasma, Cryoprecipitate Reduced, Recall # B-1359-07;
d) Recovered Plasma, Recall # B-1360-07
CODE
a) Unit: 4041220;
b) Units: 5600008, 7110721;
c) Unit: 5600008;
d) Units: 7110721, 3771359, 9704332
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile, and email on July 27, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD) due to family history, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
LA and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1433-07
CODE
Unit: 029GW50990
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by telephone on July 14, 2006 and letter dated July 27, 2006. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1444-07
CODE
Unit: 8743786
RECALLING FIRM/MANUFACTURER
Union Memorial Hospital Bb, Baltimore, MD, by letter dated June 23, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1468-07
CODE
Unit: 5825350
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on February 27, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1474-07
CODE
Unit: FR67264
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by telephone on February 14, 2004. 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
WI
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-1482-07;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1483-07
CODE
a) and b) Units: 1162662
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on April 4, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1485-07
CODE
Unit: 306594711
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone and fax on August 9, 2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, collected using an abbreviated screening process for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1487-07
CODE
Unit: 306583787
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 23, 2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, collected using an abbreviated screening process for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1489-07;
b) Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-1490-07
CODE
a) Unit: 306579512;
b) Units: 306574366 (split product)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated April 30, 2004. Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, collected from donors using an abbreviated screening process for which they were not eligible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL and ND
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced Irradiated, Recall # B-1492-07
CODE
Unit: KR13977
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on February 23, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled “leukoreduced”, but which had not undergone leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1493-07
CODE
Unit: FT10681
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter dated December 19, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the drug Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1494-07
CODE
Unit: 71X43758-9
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on March 2, 2006. 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
Red Blood Cells Leukocytes Reduced, Recall # B-1496-07
CODE
Unit: LS95174
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter dated January 5, 2004. 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
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1498-07
CODE
Unit: KC11880
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on January 13, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported having malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1501-07;
b) Fresh Frozen Plasma, Recall # B-1502-07
CODE
a) and b) Unit: J08210
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on July 18, 2006 and letter dated August 16, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and VA
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-1503-07
CODE
Unit: 4326915
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shewsbury, NJ, by fax on February 21, 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), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1504-07
CODE
Unit: 306599502
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 17, 2004. Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1509-07
CODE
Unit: LV00505
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter dated February 17, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not evaluated by the firm when returned due to possible hemolysis, was re-distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1510-07;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1511-07
CODE
a) Unit: J25560;
b) Unit: J43395
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by e-mail on July 29, 2006 and August 1, 2006, and by letter dated August 7, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA and Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1513-07
CODE
Unit: 4916582
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on October 4, 2002 and letter dated October 18, 2002. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced, but which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1514-07;
b) Platelets Irradiated, Recall # B-1515-07;
c) Fresh Frozen Plasma, Recall # B-1516-07
CODE
a) and c) Units: R69417, K91427;
b) Unit: R69417
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter dated May 26, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 components
DISTRIBUTION
VA
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Pooled, Recall # B-1517-07;
b) Recovered Plasma, Recall # B-1518-07
CODE
a) Unit: 9990686;
b) Unit: 4787531
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on February 2, 2006 and by e-mail on February 6, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and Austria
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1519-07;
b) Recovered Plasma, Recall # B-1520-07
CODE
a) and b) Units: 306559951, 306599000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on August 24, 2004 or by e-mail on August 27, 2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NV, SD, and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1521-07;
b) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1522-07
CODE
a) Units: 119937644, 119937656, 119937659, 119939859, and 119939869;
b) Units: 119937647 (1), 119937647 (2), 119937652 (1), 119937652 (2), 119939853 (1), 119939853 (2), 119939806, 119939835, 119939840 (1), and 119939840 (2)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, El Paso, TX, by facsimile on February 7 – 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have complete medical history interviews, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
TX, NM and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1524-07;
b) Fresh Frozen Plasma, Recall # B-1525-07
CODE
a) Units: 0234948, 0162873;
b) Unit: 0162873
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on January 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1526-07
CODE
Unit: 53GR77550
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by letter and e-mail dated June 7, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 component
DISTRIBUTION
MD and CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1533-07
CODE
Unit: 71P248874
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on December 2, 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
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1534-07
CODE
Unit: FK28979
RECALLING FIRM/MANUFACTURER
Heartland Blood Centers, Aurora, IL, by letter dated March 21, 2007. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1536-07
CODE
Unit: 2873632
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on September 19, 2006 and follow-up letter on September 20, 2006. Firm initiated recall is complete.
REASON
Blood product, tested for viral markers using a sample that was possibly diluted, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1561-07
b) Recovered Plasma, Recall # B-1562-07
CODE
a) Unit: 4935838;
b) Units: 4890038, 4881091, 4798285, 4789450, 4753329 and 1422239
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 18, 2006 and email on July 24, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
FL and Austria
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1486-07
CODE
Unit: 306594711
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone and fax on August 9, 2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, collected using an abbreviated screening process for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND and Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1488-07
CODE
Unit: 306583787
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by e-mail on June 23, 2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, collected using an abbreviated screening process, for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1491-07
CODE
Unit: 306579512
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by e-mail on April 4, 2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, collected from donor using an abbreviated screening process for which they was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1495-07
CODE
Unit: 5795028
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by e-mail on February 17, 2006. Firm initiated recall is complete.
REASON
Blood product, stored at an elevated temperature, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1497-07
CODE
Unit: 306564803
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 22, 2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1505-07;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1506-07
CODE
a) Unit: 163867610;
b) Unit: 163867612
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on December 6, 2005.
Manufacturer: Blood Systems, Inc./dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, collected using a scale that had unacceptable quality control results documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1507-07;
b) Recovered Plasma, Recall # B-1508-07
CODE
a) and b) Unit: 4031171
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by fax and e-mail on October 11, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA and Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1512-07
CODE
Units: J25560, J43395
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by e-mail on July 29, 2006 and August 1, 2006, and by letter dated August 7, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA and Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1523-07
CODE
Units: 119937644, 119937656, 119939826, 119939851, 119939875, 119939859, and 119939869
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, El Paso, TX, by facsimile on February 7 – 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have complete medical history interviews, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX, NM and Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1527-07
CODE
Unit: 53GR77550
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by letter and e-mail dated June 7, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 component
DISTRIBUTION
MD and CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1535-07
CODE
Unit: 36FT06715
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by telephone on October 7, 2005 and by letter dated October 11, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for Leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
a) Clinical Chemistry Lipase, in vitro diagnostic test reagent.
List Numbers: 7D80-20 and 7D80-30, Recall # Z-1232-2007;
b) MULTIGENT Acetaminophen, in vitro diagnostic test reagent.
List Number 2K99-20, Recall # Z-1233-2007
CODE
a) Control Numbers: 37033HW00, 33032HW00, 30053HW00, 47048HW00,
45067HW00, 43002HW00, 42016HW00 & 42010HW00;
b) Control Numbers: 30455UQ11 & 31046UQ02
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., South Pasadena, CA, by letters on June 1, 2007. Firm initiated recall is ongoing.
REASON
Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.
VOLUME OF PRODUCT IN COMMERCE
7,602 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** Recall # Z-1234-2007
CODE
Part Number: 4450028-01; Serial Numbers: 73343, 74482, 74481, 74480, 74477, 74478, 74479, 74639, 74637, 74640, 74638, 74641, 74758, 79281, 79279, 79282, 79278, 79280, 79348, 79347, 79345, 79346, 79512, 79513, 79514, 79511, 79515, 79582, 79699, 79698, 79696, 79697, 79700, 79778, 79774, 79776, 79773, 79775, 79772, 79777, 79898, 79899, 79893, 79894, 79892, 79897, 79896, 79891, 79895, 79976, 79980, 79978, 79975, 79977, 79979, 79974, 80060, 80132, 80125, 80127, 80123, 80124, 80131, 80161, 80128, 80130, 80129, 80126, 80571, 80570, 80574, 80579, 80577, 80572, 80573, 80578, 80575, 80576, 80729, 80730, 80894, 80895, 80896, 80934, 80932, 80897, 80931, 80933, 80935, 80848, 81007, 81004, 81008, 81005, 81010, 81009, 81006, 81090, 81091, 81095, 81093, 81089, 81092, 91094, 746390. Part Number 4450028-02; Serial Numbers: 80583, 81116, 81121, 81117, 81115, 81119, 81128, 81118, 81120, 81126, 81122, 81123, 81125, 81127, 81124, 81129, 81168, 81165, 81169, 81167, 81166, 81170, 81179, 81177, 81171, 81175, 81176, 81351, 81354, 81347, 81348, 81349, 81353, 81350, 81346, 81355, 81352, 81173, 81174, 81172, 81178, 81446, 81454, 81458, 81459, 81455, 81448, 81445, 81449, 81447, 81456, 81457, 81453, 81451, 81452, 81450, 81826, 81830, 81827, 81829, 81828, 81851, 81853, 81852, 81854, 81855, 82053, 82054, 82051, 82052, 82050, 82114, 82112, 82113, 82116, 82119, 82115, 82117, 82120, 82121, 82118, 82154, 82156, 82155, 82157, 82153, 82267, 82266, 82273, 82268, 82265, 82269, 82274, 82271, 82272, 82270, 82387, 82386, 82385, 82383, 82384, 82472, 82473, 82476, 82474, 82475, 82519, 82521, 82518, 82517, 82520, 82604, 82600, 82598, 82603, 82602, 82599, 82607, 82605, 82606, 82601, 82705, 82708, 82707, 82704, 82706, 82798, 82797, 82801, 82799, 82800, 82928, 82927, 82926, 82924, 82925, 83010, 83011, 83012, 83014, 83013, 83109, 83108, 83107, 83106, 83115, 83112, 83110, 83111, 83113, 83114, 83156, 83157, 83158, 83159, 83160, 83155, 83161, 83164, 83162, 83276, 83269, 83272, 83273, 83163, 83271, 83274, 83275, 83277, 83270, 83278, 83381, 83378, 83380, 83375, 83377, 83373, 83374, 83379, 83382, 83376, 73546, 83543, 83548, 83543, 83547, 83544, 83549, 83550, 83551, 83552, 83675, 83676, 83673, 83678, 83681, 83679, 83677, 83674, 83672, 83680, 83748, 83746, 83745, 83744, 83747, 83882, 83878, 83875, 83876, 83877, 83880, 83883, 83884, 83879, 83881, 83881, 83884, 83879, 83880, 83883, 84010, 84014, 84009, 84013, 84008, 84011, 84012, 84016, 84007, 84015, 84065, 84064, 84066, 84072, 84071, 84070, 84069, 84067, 84068, 84073, 84209, 84211, 84212, 84213, 84207, 84210, 84208, 84215, 84216, 84236, 84239, 84233, 84237, 84231, 84235, 84238, 84240, 84232, 84234, 83672, 84519, 84517, 84514, 84516, 84515, 84513, 83877, 83878, 84518, 84520, 84523, 84525, 84526, 84521, 84524, 84522, 84527, 84597, 84598, 84595, 84599, 84596, 84600, 84849, 84854, 84853, 84852, 84850, 84848, 84855, 84851, 84857, 84856, 85014, 85007, 85012, 85006, 85010, 85011, 85009, 85015, 85005, 85016, 85008, 85013, 85017, 85004, 85003, 83678, 85148, 85151, 85149, 85154, 85156, 85152, 85150, 85155, 85157, 85253, 85256, 85258, 85259, 85257, 85254, 85252, 85255, 85153, 85262, 85261, 85260, 85263, 85265, 85264, 85266, 85281, 85282, 85283, 85284, 85286, 85289, 85290, 85287, 85285, 85288, 85320, 85318, 85314, 85313, 85317, 85321, 85316, 85322, 85323, 85325, 85327, 85319, 85333, 85324, 85326, 85332, 85347, 85330, 85315, 85349, 85348, 85336, 85335, 85334, 85337, 85351, 85340, 85353, 85350, 85355, 85339, 85356, 85374, 85352, 85354, 85372, 85371, 85373, 85379, 85378, 85377, 85376, 85375, 85380, 85790, 85791, 85792, 85786, 85785, 85793, 85788, 85784, 85787, 85789
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on September 4, 2007.
Manufacturer: Teal Electronics Corp., San Diego, CA. Firm initiated recall is ongoing.
REASON
The TEAL Power Conditioning units may fail and result in the unit emitting fire and/or smoke. Note: the TEAL Power Conditioning Unit has the potential to fail when the scanner that is attached to the TEAL is powered and in use as well as when not in use.
VOLUME OF PRODUCT IN COMMERCE
491 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
a) Diamond Pet SG PMX #1, NB-8244A, packaged in 50-lb. bags, For Manufacturing
Purposes Only, Recall # V-076-2007;
b) Diamond Pet SG PMX #2, NB-8332A, packaged in 50-lb. bags, For Manufacturing
Purposes Only, Recall # V-077-2007;
c) Diamond Holistic Premix, NB-8866B, packaged in 50-lb. bags, For Manufacturing
Purposes Only, Recall # V-078-2007;
d) Kirkland Signature Premix, NB8251A, packaged in 50-lb. bags, For Manufacturing
Purposes Only, Recall # V-079-2007
CODE
a) Lots: 0507721, 0507723, and 0521755;
b) Lots: 0514713 and 0521757;
c) Lots: 0510711, 0510713, 0517749, 0521759, 0521761, 0521763, 0601707, 0601709,
0601711, and 0807747;
d) Lots: 0503737, 0504701, 0510717, 0510719, 0523753, 0601713, 0713709, and
0718733
RECALLING FIRM/MANUFACTURER
Nutra Blend LLC, Neosho, MO, by telephone on August 22, 2007 and August 24, 2007, and by letter on August 23, 2007. Firm initiated recall is complete.
REASON
Some of the raw material dehydrated parsley powder used in the manufacture of the premixes was found to contain salmonella.
VOLUME OF PRODUCT IN COMMERCE
86,700 lbs.
DISTRIBUTION
MO, SC, and CA
END OF ENFORCEMENT REPORT FOR SEPTEMBER 19, 2007
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