FDA

Enforcement Report

March 19, 2003
03-12

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

_____________________________
PRODUCT
Mixed vegetables in poly packages stating in part "Schwan's STIR-FRY VEGETABLES ** Net WT. 32 OZ. ***". Recall # F-250-3.
CODE
X7217218:00 L4 through X7217218:59 L4.
RECALLING FIRM/MANUFACTURER
Recalling Firm: J. R. Simplot Company, Boise, ID, by telephone and letter on September 25, 2002 and press release on September 27, 2002.
Manufacturer: J. R. Simplot Company, Quincy, WA. Firm initiated recall is complete.
REASON
The bags actually contained a different product, Fire Roasted Vegetable Blend. The Fire Roasted Vegetable Blend contains ingredients including nonfat milk, which are not listed on the label of the Stir-Fry Vegetables Blend.
VOLUME OF PRODUCT IN COMMERCE
297 cases.
DISTRIBUTION
MN.

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PRODUCT
SoBe Tsunami Orange Cream Flavored Beverage with a Blend of
Taurine, Guarana & Zinc, packaged in 20-fl. oz. single-serve clear glass bottles, 12 bottles per case.
Recall # F-251-3.
CODE
AUG 11 03 CT823/XXXX VG080722 (X = military time).
RECALLING FIRM/MANUFACTURER
Recalling Firm: South Beach Beverage Co. Norwalk, CT, by memo's on September 19, 2002 and by memo's and press release on September 20, 2002.
Manufacturer: American Beverage Co. St. Louis, MO. Firm initiated recall is complete.
REASON
The product was labeled with the ingredient statement for a different product, SoBe Green Tea. The SoBe Tsunami Orange Cream Flavored Beverage contains skim milk and cream that are not listed in the SoBe Green Tea ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
17,820/12/20-fl. oz. bottle cases.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

___________________________
PRODUCT
Human Tissue for Transplantation, Cornea.
Recall # B-0525-3.
CODE
Number LA-2002-07-031L1.
RECALLING FIRM/MANUFACTURER
Iowa Lions Eye Bank, Iowa City, IA, by telephone on July 18, 2002. Firm initiated recall is complete.
REASON
Cornea, collected from a donor whose serum tested negative for Human Immunodeficiency Virus (HIV) 1/2 antibody, but subsequently tested positive for HIV-1 p24, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 cornea.
DISTRIBUTION
IL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_____________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0588-3.
CODE
Unit FT98256.
RECALLING FIRM/MANUFACTURER
Inova Health System/Blood Donor Services, Annandale, VA, by
letter dated September 26, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an HIV group O high risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0595-3;
b) Recovered Plasma. Recall # B-0596-3.
CODE
a) and b) Units 03LS14373, 03LS13398, 03LS12752.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Atlanta, GA, by letter dated March 21, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to subsequent disclosure of a prior positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
GA

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0602-3.
CODE
Unit 18FS60076.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by letter dated August 20, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

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PRODUCT
Platelets Pheresis. Recall # B-0603-3.
CODE
Units 18P48652 and 18P48681.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by letter dated March 28, 2002. Firm initiated recall is complete.
REASON
Platelets Pheresis labeled with incorrect platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0611-3.
CODE
Unit 38FK20364.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on April 26, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0612-3.
b) Recovered Plasma. Recall # B-0613-3.
CODE
a) and b) unit numbers 38J47239, 38J46882, 38J46542, 38J46220, and 38J45813.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region
Fort Wayne, IN, by telephone, facsimile, and letter between September 23, 2002 and January 14, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
IN, MD, and Switzerland.

_____________________________
PRODUCT
Corneas. Recall # B-0615-3.
CODE
Tissue numbers 2002-12-2027 and 2002-12-2028.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by letter on January 28, 2003.
Manufacturer: Heartland Lions Eye Banks - Illinois Branch, Springfield, IL. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
Germany.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0616-3;
b) Recovered Plasma. Recall # B-0617-3.
CODE
a) and b) Unit numbers 38FM27637 and 38FM25308.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by facsimile or letter on June 27, 2002 and July 26, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV -1/2), but were collected from a donor that was subsequently determined to have a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
IN, CA, and NY.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0618-3;
b) Recovered Plasma. Recall # B-0619-3.
CODE
a) and b) unit number 12FZ95751.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone and letter on July 31, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC, and CA.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0620-3;
b) Platelets. Recall # B-0621-3.
CODE
a) and b) Unit 9256595.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, Delaware, by letter dated January 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm preparation may not have been performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD, and DE.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0622-3;
b) Cryoprecipitated AHF. Recall # B-0623-3;
c) Cryoreduced Plasma. Recall # B-0624-3.
CODE
a), b) and c) Units 12FQ52349; 12FQ54507; and 12FQ56126.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on August 21, 2002, and by letter dated August 23, 2002. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor with a history of having tested positive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
GA, NC, and TN.

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PRODUCT
a) Red Blood Cells. Recall # B-0625-3;
b) Cryoprecipitate. Recall # B-0626-3;
c) Recovered Plasma. Recall # B-0627-3.
CODE
a), b) and c) Unit 0693783.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, Ohio, by fax dated September 3, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of
jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH, and Switzerland.

_____________________________
PRODUCT
Recovered Plasma. Recall # B-0628-3.
CODE
Unit 01GG60163.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by a Questionable Plasma Inquiry on May 8, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Multiple Sclerosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Red Blood Cells. Recall # B-0632-3.
CODE
Unit number 5225719.
RECALLING FIRM/MANUFACTURER
Naval Hospital - Charleston, North Charleston, SC, by letter on June 30, 2001. Firm initiated recall is complete.
REASON
Blood product, that tested reactive for the antibody to hepatitis B core antigen to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_____________________________
PRODUCT
a) Red Blood Cells. Recall #B-0634-3;
b) Red Blood Cells, Leukocytes Reduced. Recall #B-0635-3;
c) Cryoprecipitated AHF. Recall #B-0636-3;
d) Recovered Plasma. Recall #B-0637-3.
CODE
a) unit number 12LK25669;
b) and c) unit number 12FR62565;
d) unit numbers 12LK25669 and 12FR62565.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone and by letter on January 31, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for syphilis, but were collected from an ineligible donor based on previous reactive testing for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NC, CA, and Switzerland.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0638-3.
CODE
Unit numbers 42FS75519, 42E38738, and 42Q74226.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter on October 23, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0643-3.
CODE
Unit number 12475-4036.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated August 20, 2002.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is ongoing.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NM.

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0650-3.
CODE
Unit number 1270353.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on June 4, 2001. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0651-3
CODE
Unit number 9216720.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by letter on December 28, 2001. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_____________________________
PRODUCT
Platelets Pheresis. Recall # B-0652-3,
CODE
Unit number 9256138.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by letter on January 28, 2002. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
DE.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0653-3.
CODE
Unit number 8004343.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by letter on May 13, 2000. Firm initiated recall is complete.
REASON
Blood product, that was labeled negative for Cytomegalovirus (CMV) based on the results of incorrect testing and was subsequently found to test positive for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
DE.

_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0654-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0655-3;
c) Recovered Plasma. Recall # B-0656-3.
CODE
a) Unit number KX06600;
b) Unit number 0725012;
c) Unit number KX06600 and 0725012.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letters on June 18 and 19, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0657-3.
CODE
Unit number 0657325.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter on July 23, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0658-3.
CODE
Unit number 0663308.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter on August 13, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

__________________________
PRODUCT
Corneas. Recall # B-0659.
CODE
Tissue numbers 02-1506 OD and 02-1506 OS.
RECALLING FIRM/MANUFACTURER
Northwest Lions Eye Bank, Seattle, WA, by telephone and electronic mail on January 13, 2003 and by letter dated January 15, 2003. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for viral markers, but was procured from a donor that participated in behavior known to increase risk of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
WA.

END OF ENFORCEMENT REPORT FOR MARCH 19, 2003

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