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U.S. Department of Health and Human Services

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Enforcement Report for July 16, 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 16, 2008
08-28

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
a) Harry & David Bake Shop brand Oatmeal Chocolate Chip Cookie Mix
in 1 lb. 2 oz. or 1 lb. 5 oz. clear glass jars labeled with hang tags attached to the top
of the jars and price stickers affixed to the bottom of the jar, Recall # F-423-8;
b) Harry & David Bake Shop brand Cranberry Vanilla Chip Cookie Mix packaged
in 1 lb. 2 oz. or 1 lb. 5 oz. glass jars labeled with hang tags attached to the top
of the jars and price stickers affixed to the bottom of the jar, Recall # F-424-8;
c) Harry & David Bake Shop brand Chocolate Peanut Butter Cookie Mix in
1 lb. 2 oz. or 1 lb. 5 oz. glass jars labeled with hang tags attached to the top
of the jars and price stickers affixed to the bottom of the jar, Recall # F-425-8;
CODE
a) Lot codes 121207 or 110907;
b) Lot codes 111407 or 111207;
c) Lot codes 111407 or 110907
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bear Creek Operations, Inc., DBA Harry and David’s, Medford, OR, by e-mail on December 6, 2007 and press release on December 7, 2007.
Manufacturer: Sisters’ Gourmet, Inc., Winder, GA. Firm initiated recall is complete.
REASON
a) Jars labeled as Oatmeal Chocolate Chip Cookie Mix may actually contain
Cranberry Vanilla Chip Cookie Mix with milk ingredients or may contain
Chocolate Peanut Butter Cookie Mix with peanut and milk ingredients.
The Oatmeal Chocolate Chip Cookie Mix does not list milk or peanut as ingredients;
b) Jars labeled as Cranberry Vanilla Chip Cookie Mix may actually contain
Oatmeal Chocolate Chip Cookie Mix with soybeans and coconut or may contain
Chocolate Peanut Butter Cookie Mix with peanuts. The label of the Cranberry
Vanilla Chip Cookie Mix does not list soybeans, coconut or peanut as ingredients;
c) Jars labeled as Chocolate Peanut Butter Cookie Mix may actually contain
Oatmeal Chocolate Chip Cookie Mix with soybeans and coconut or may contain
Cranberry Vanilla Chip Cookie Mix. The label of the Chocolate Peanut Butter Cookie
Mix does not list soybean or coconut as ingredients.
VOLUME OF PRODUCT IN COMMERCE
1,309 Oatmeal; 1,296 Cranberry; 1,309 Peanutbutter cookie mix
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Mike’s Melons, Cantaloupes. Produce of Honduras, Recall # F-426-8
CODE
All cantaloupe shipped on or after February 21, 2008 through March 20, 2008.
RECALLING FIRM/MANUFACTURER
Recalling Firm: C. H. Robinson International, Inc., Eden Prairie, MN, by press release, telephone, e-mail and fax beginning March 22, 2008.
Manufacturer: Agropecuaria Montelibano, Puerto Cortes, Honduras. Firm initiated recall is ongoing.
REASON
Cantaloupes associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
49,348 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Whole Foods Market 365 Organic Everyday Value Organic Swiss Milk Chocolate
with Rice Crisps, 3 oz. (85g); UPC #99482 41730, Recall # F-427-8;
b) Whole Foods Market 365 Organic Everyday Value Organic Swiss Dark
Chocolate with Coconut Flakes, 3 oz. (85g); UPC #99482 41731, Recall # F-428-8;
c) Whole Foods Market 365 Organic Everyday Value Organic Swiss Dark Chocolate
with Mint Crisps, 3 oz. (85g); UPC #99482 41729, Recall # F-429-8;
d) Whole Foods Market 365 Organic Everyday Value Organic Swiss Milk Chocolate,
3 oz. (85g); UPC #99482 40805, Recall # F-430-8;
e) Whole Foods Market 365 Organic Everyday Value Organic Swiss Milk Chocolate
with Hazelnuts, 3 oz. (85g); UPC #99482 40806, Recall # F-431-8;
f) Whole Foods Market 365 Organic Everyday Value Organic Swiss Milk Chocolate
with Almonds, 3 oz. (85g); UPC #99482 40807, Recall # F-432-8;
g) Whole Foods Market 365 Organic Everyday Value Organic Swiss Dark Chocolate,
3 oz. (85g); UPC #99482 40808, Recall # F-433-8;
h) Whole Foods Market 365 Organic Everyday Value Organic Swiss Dark Chocolate
with Almonds, 3 OZ. (85g); UPC #99482 40809, Recall # F-434-8
CODE
a) Best If Used By date prior to 11/8/09 and Best If Used By date of 11/21/07;
b) thru h) Best If Used By date prior to 11/08/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market, Austin, TX, by e-mail on December 14, 2007 and December 21, 2007.
Manufacturer: Chocolat Bernrain, Kreuzlingen 4, Switzerland. Firm initiated recall is complete.
REASON
The products may contain allergens such as tree nuts and milk due to cross contact at the manufacturer.
VOLUME OF PRODUCT IN COMMERCE
1,133,732
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Dole Cantaloupes, in cardboard cartons with the brand “Dole” and “Product of Honduras” printed on each side panels of the carton, Recall # F-435-8
CODE
No coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dole Fresh Fruit Co., Westlake Village, CA, by telephone on March 22, 2008 and by letter on March 24, 2008 and March 28, 2008 and by press release on March 28, 2008.
Manufacturer: Agropecuaria Montelibano, Puerto Cortes, Honduras. Firm initiated recall is ongoing.
REASON
Cantaloupes have been linked to an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
29,772 cartons
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Little Bay Baking Corn Bread & Muffin Mix Free of Gluten, Wheat, Yeast Soy,
casein, & Dairy Net Wt 12.6 oz (359g). UPC code 7 18122 05053;
b) GFCFDIET Corn Bread & Muffin Mix Free of Gluten, Wheat, Yeast Soy, casein,
& Dairy Net Wt 12.6 oz (359g, UPC code 7 18122 05053, Recall # F-436-8
CODE
No codes
RECALLING FIRM/MANUFACTURER
Red Bridge Baking Company LLC, dba Little Bay Baking Co., Newmark, NH, by telephone and letter on May 1, 2008 and by e-mail on May 2, 2008. Firm initiated recall is complete.
REASON
Products are labeled as soy-free but were manufactured using an ingredient (cornmeal) that may contain traces of soybeans.
VOLUME OF PRODUCT IN COMMERCE
557 bags
DISTRIBUTION
NH, FL, CT, RI and ME

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
FruitSmart brand 70 Pear Juice Concentrate packaged in a double lined 55 gallon steel drum with a fill of 52 gallons, Net Wt: 584 Lbs. and Gross Wt: 624 lbs, Recall # F-438-8
CODE
Lot # 027PR8 and 090PR8 (027 - sequential batch number for the year; PR - pear juice; 8 -year)
RECALLING FIRM/MANUFACTURER
FruitSmart, Inc., Prosser, WA, by telephone and letter on May 16, 2008. Firm initiated recall is complete.
REASON
Pear concentrate contains elevated levels of arsenic.
VOLUME OF PRODUCT IN COMMERCE
58 drums
DISTRIBUTION
WA

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Margaret Holmes Seasoned Mustard Greens, Net. Wt. 27 oz. HEAT-N-SERVE. The product is packed in metal cans with UPC code 41443 11234, Recall # F-437-8
CODE
Number: MUST3 K17HX
RECALLING FIRM/MANUFACTURER
McCall Farms, Inc., Effingham, SC, by letter on/about April 11, 2008. Firm initiated recall is ongoing.
REASON
Product contains pesticide residue - permethrin.
VOLUME OF PRODUCT IN COMMERCE
1,884 cases; 12/27 oz. cans per case
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Carbamazepine (Chewable) Tablets USP, 100mg, 100 tablets (10x10) unit dose blister packs, Recall # D-238-2008
CODE
Lot # 073553, Exp. Date 7/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on April 1, 2008.
Manufacturer: Taro Pharmaceuticals Industries U.S.A., Inc., Haifa Bay, Israel. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specification: 6 month stability timepoint.
VOLUME OF PRODUCT IN COMMERCE
1,078/100mg tablet blister packs
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Menopur (menotropins for injection, USP), 75 IU, carton containing: 5 single-dose vials of Menotropins for Injection, 5 single-dose vials of 0.9% Sodium Chloride Injection, and 5 Q-Cap Vial Adapters, Rx only. Outer carton NDC 55566-7501-2, Recalling # D-240-2008
CODE
Lots: CB0613A-1, exp. 5/09 and CB0613A-2, exp 5/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals, Inc., Parsippany, NJ, by letters on May 30, 2008.
Manufacturer: Ferring GmbH, Kiel, Germany. Firm initiated recall is ongoing.
REASON
Outer carton label contains a misprint of active ingredients. Label lists 75 IU of FSH twice when it should read 75 IU of FSH and 75 IU of LH.
VOLUME OF PRODUCT IN COMMERCE
15,955 cartons
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1182-08
CODE
Units: 9624568, 2150538, 9624353, 9624918, 9624845, and 2147690
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on August 8, 2007. Firm initiated recall is complete.
REASON
Blood products, mislabeled as crossmatch compatible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CO
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1459-08
CODE
N25603
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated June 19, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1461-08
CODE
X70545
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated June 19, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor who had lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1470-08
CODE
Units: LC81808, LC16818, LC52391
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by 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
3 units
DISTRIBUTION
FL, NY and TX
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1473-08;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1474-08;
c) Platelets, Leukocytes Reduced, Recall # B-1475-08
CODE
a) and c) Unit: 13LH46776;
b) Unit: 13FW55839
RECALLING FIRM/MANUFACTURER
American National Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on December 24, 2007 and by letter dated January 4, 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
3 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1514-08
CODE
Unit: 17FX88745
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by letter on July 1, 2005. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # 1548-08;
b) Fresh Frozen Plasma, Recall # B-1549-08
CODE
a) and b) Unit: 6736710
RECALLING FIRM/MANUFACTURER
The Blood Centers of New Jersey, East Orange, NJ, by telephone on August 30, 2005. Firm initiated recall is complete.
REASON
Blood product, incorrectly tested for West Nile Virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 components
DISTRIBUTION
NJ and SC
___________________________________
PRODUCT
Source Plasma, Recall # B-1550-08
CODE
Unit: DQ038692
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 30, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-1551-08
CODE
Unit: DQ039464
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-1552-08
CODE
Units: DQ039831; DQ039655; DQ039300; DQ039140; DQ038689
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # 1553-08
CODE
Units: DQ038695; DQ038529
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # 1554-08
CODE
Units: DQ036948
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1555-08
CODE
Unit: 9108422
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by telephone and follow-up letter on March 14, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Source Plasma, Recall # 1556-08
CODE
Units: DQ039406; DQ039148; DQ038120; DQ037963
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-1557-08
CODE
Unit: 0040110782
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Beaumont, TX, by fax on July 28, 2007. Firm initiated recall is complete.
REASON
Blood product, contaminated with air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Barcelona, Spain
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1558-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1559-08;
c) Cryoprecipitated AHF, Recall # B-1560-08;
d) Cryoprecipitated AHF, Pooled, Recall # B-1561-08;
e) Frozen Plasma, Recall # B-1562-08
CODE
a) Units 40GF81982, 40GF81991;
b) Units 40GF81990, 40GF81994, 40GF82008, 40LT29239, 40LT29295,
40LT29341, 40LT29361, 40LT29218, 40LT29232;
c) Unit 40LT29239;
d) Pool 2010 - unit 40LT29218;
e) Unit 40GF81982
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria, IL, by fax on February 5 and 6, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
IL and MO
___________________________________
PRODUCT
Source Plasma, Recall # B-1573-08
CODE
Units: I58050365, I58049839, I58048063, I58047744, I58040039, I58039373, I58038193, I58037597, I58037297, I58033810, and I58026933
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Baton Rouge, LA, by facsimile on April 17, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Leukocytes Reduced Irradiated, Recall # B-1574-08
CODE
Unit: X53234
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on November 28, 2006 and letter dated December 8, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Source Plasma, Recall # B-1575-08
CODE
Units: I59061493, I59061305, I59060838, I59060421, I59060203, I59059677, and I59055731
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Lafayette, LA, by facsimile on March 31, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1576-08
CODE
Unit: 4406554
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by electronic mail on May 18, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1577-08;
b) Recovered Plasma, Recall # B-1578-08
CODE
a) and b) Units: N61989
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter and fax on October 13, 2007. Firm initiated recall is complete.
REASON
Blood products collected from a donor considered to be at increased risk for variant Creutzfeld-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ and Vienna, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1586-08
CODE
Unit: N03702
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by facsimile on May 24, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma, Recall # B-1599-08
CODE
Units: DQ039727, DQ039493, DQ038996
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1600-08
CODE
Unit: 197529692
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by letter dated January 3, 2005 and March 11, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor using an abbreviated screening process for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1601-08
CODE
Unit: 084T14299
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter on January 25, 5005. 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
Red Blood Cells Leukocytes Reduced, Recall # B-1602-08
CODE
Units: 084W61968, 084W63442
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by facsimile and letter on January 28, 5005. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1603-08
CODE
Unit: 084T15021
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by fax and letter on December 15, 5004 and January 19, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel through a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1604-08
CODE
Unit: 197633423
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by letter on January 6, 2005. 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
NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1606-08
CODE
Unit: 197549096
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by letter on May 9, 2005. 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
NV

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1570-08;
b) Platelets, Recall # B-1571-08;
c) Fresh Frozen Plasma, Recall # B-1572-08
CODE
a) Unit: 5783766;
b) and c) Units: 5783766, 4050860
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on December 13, 2005 and by telephone on December 13 and December 14, 2005. 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
5 units
DISTRIBUTION
LA, MI
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1581-08;
b) Recovered Plasma, Recall # B-1582-08
CODE
a) and b) Unit: LT41949
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank dba UBS Central Coast, Ventura, CA, by telephone or facsimile on July 2, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1583-08
CODE
Unit: LT28475
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank dba UBS Central Coast, Ventura, CA, by letter dated July 25, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was receiving Factor VIII medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1587-08
CODE
Units: 003KM35416; 003KM35418; 003KM35419; 003KM35420; 003KM35421; 003KM35422; 003KM35423; 003KM35424
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Douglasville, GA, by telephone on September 28, 2006 and by letter dated October 3, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1605-08
CODE
Unit: 197633423
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by e-mail on January 6, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1607-08
CODE
Unit: 197549096
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by e-mail on May 9, 2005. 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

END OF ENFORCEMENT REPORT FOR JULY 16, 2008

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