FDA

Enforcement Report

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.

February 14, 2001                                                  01-06

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

__________
PRODUCTS:  
a) Red Blood Cells. Recall #B-388-1;  b) Recovered Plasma.  Recall #B-
389-1
CODE:
a) Unit  23140-5067;  b)  Unit  23140-5067
MANUFACTURER:     
United Blood Services,  Billings, MT 
RECALLED BY:	
Blood Systems, Inc.  Scottsdale, AZ by telephone on October 23, 2000 and 
by letter dated November 3, 2000.  Firm-initiated recall complete. 
DISTRIBUTION:
Montana.  
QUANTITY:
Two units.
REASON:   
Blood products, collected in a manner that compromised the sterility of 
the units, were distributed.	
_________
PRODUCT:
Red Blood Cells, Leukocyte Reduced. Recall #B-435-1.
CODE:
Unit 612942.
MANUFACTURER:
Blood Centers of the Pacific, Peninsula South Bay Center, Burlingame, CA.
RECALLED BY:
Blood Centers of the Pacific, Irwin Center, San Francisco, CA. by letter 
dated October 20, 1999.  Firm-initiated recall complete.
DISTRIBUTION:
California.
QUANTITY:
One unit.
REASON: 	
Blood product, which was collected from a donor who traveled to a malaria 
endemic area, was distributed.
_________
PRODUCT:
Source Plasma.  Recall #B-439-1.
CODE:
Units 98AIAB5307; 98AIAB5536; 98AIAB5895; 98AIAB5957.
MANUFACTURER:
Community Bio-Resources, Inc., Ames, IA.
RECALLED BY:
Manufacturer, by facsimile dated January 4, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
Austria
QUANTITY:
Four units.
REASON:
Blood products, collected from a donor whose partner had tested positive 
for Hepatitis B, were distributed.
_________
PRODUCT:
Platelet, Pheresis.  Recall #B-450-1.
CODE:
Unit 09P63386.
MANUFACTURER:
American Red Cross Blood Services, Midwest Region, Omaha, NE.
RECALLED BY:
Manufacturer, by telephone on December 30, 1997. Firm-initiated recall 
complete.
DISTRIBUTION:
Nebraska
QUANTITY:
One unit.
REASON:
Blood product, mislabeled as CMV antibody negative was shipped.
_________
PRODUCT:
a)Red Blood Cells, Recall #B-455-1; b) Platelets, Recall #B-456-1; c) 
Recovered Plasma. Recall #B-457-1.
CODE:
a) Units 18S42122 and 18R53862; b) unit 18R53862; c) units 18S42122 and 
18R53862.
MANUFACTURER:
American Red Cross, Great Lakes Region, Lansing, MI.
RECALLED BY:
Manufacturer, by letters dated April 2 and 3, 1998. Firm-initiated recall 
complete.
DISTRIBUTION:
Michigan.
QUANTITY:
Five units.
REASON:
Blood products, which were collected from a donor who had close contact 
with an individual with hepatitis, were distributed.
_________
PRODUCT:
a)Red Blood Cells, Recall #B-458-1; b) Platelets, Recall #B-459-1; c) 
Fresh Frozen Plasma. Recall #B-460-1.
CODE:
a) Unit 3443670; b) unit 3443670; c) units 3443670.
MANUFACTURER:
Michigan Community Blood Centers, Grand Valley Blood Program, Grand 
Rapids, MI.
RECALLED BY:
Manufacturer, by letter dated December l0, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
Michigan.
QUANTITY:
Three units.
REASON:
Blood products, which were collected from a donor who had a history of 
jaundice, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-461-1; b) Platelets, Recall #B-462-1; c) 
Cryoprecipitated AHF. Recall #B-463-1; d) Recovered Plasma.  Recall #B-
464-1.
CODE:
a) Units 6240871 and 6238468; b) unit 6240871; c) unit 6238468; d) units 
6240871 and 6238468.
MANUFACTURER:
Michigan Community Blood Centers, Grand Valley Blood Program, Grand 
Rapids, MI.
RECALLED BY:
Manufacturer, by letter dated December l0, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
Michigan, Texas, and Switzerland.
QUANTITY:
Six units.
REASON:
Blood products, which were collected from a donor who had a history of 
jaundice, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-465-1; b)Fresh Frozen Plasma. Recall #B-466-
1.
CODE:
a) Unit 8120965; b) unit 8120965.
MANUFACTURER:
Michigan Community Blood Centers, Traverse City, MI.
RECALLED BY:
Manufacturer, by letter dated September l4, 1998. Firm-initiated recall 
complete.
DISTRIBUTION:
Michigan.
QUANTITY:
Two units.
REASON:
Blood products, which were collected from a donor who had a history of 
jaundice, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-467-1; b) Platelets, Recall #B-468-1; c) 
Recovered Plasma. Recall #B-469-1.
CODE:
a) Unit 27V70270; b) unit 27V70270; c) units 27V70270.
MANUFACTURER:
American Red Cross Blood Services, Johnstown Region, Johnstown, PA..
RECALLED BY:
Manufacturer, by letter dated July l9, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
West Virginia.
QUANTITY:
Three units.
REASON:
Blood products, collected from a donor with a history of having tested 
positive for hepatitis, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-470-1; b)Recovered Plasma. Recall #B-471-1.
CODE:
a) Units 27FC81229, 27Y66597; b) units 27FC81229, 27Y66597.
MANUFACTURER:
American Red Cross Blood Services, Johnstown Region, Johnstown, PA..
RECALLED BY:
Manufacturer, by letter dated February l6, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
Pennsylvania and Virginia.
QUANTITY:
Four units.
REASON:
Blood products, collected from a donor with a history of having tested 
positive for hepatitis C, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-472-1; b) Fresh Frozen Plasma. Recall #B-
473-1.
CODE:
a) Unit 27GJ13845; b) unit 27GJ13845.
MANUFACTURER:
American Red Cross Blood Services, Johnstown Region, Johnstown, PA..
RECALLED BY:
Manufacturer, by letter dated February 8, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
Pennsylvania.
QUANTITY:
Two units.
REASON:
Blood products, collected from a donor with a history of having tested 
positive for hepatitis, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-474-1; b) Platelets, Recall #B-475-1; 
c)Fresh Frozen Plasma. Recall #B-476-1; d) Recovered Plasma. Recall #B-
477-1.
CODE:
a) Units 27GX00670, 27GW05537, 27GV42240; b) unit 27GV42240; c) units 
27GV42240;  d) units 27GX00670, 27GW05537.
MANUFACTURER:
American Red Cross Blood Services, Johnstown Region, Johnstown, PA..
RECALLED BY:
Manufacturer, by letter dated May l0, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
Pennsylvania and West Virginia.
QUANTITY:
Seven units.
REASON:
Blood products, collected from a donor who provided post donation 
information regarding high risk behaviors, and a positive test for 
Hepatitis B, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-478-1; b) Recovered Plasma. Recall #B-479-1.
CODE:
a) Unit 27W82103; b) units 27W82103, 27GK00294. 
MANUFACTURER:
American Red Cross Blood Services, Johnstown Region, Johnstown, PA..
RECALLED BY:
Manufacturer, by letters dated May 26, 1999 June 29, 1999. Firm-initiated 
recall complete.
DISTRIBUTION:
Pennsylvania.
QUANTITY:
Three units.
REASON:
Blood products, collected from a donor with a history of having tested 
positive for hepatitis, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-480-1; b) Recovered Plasma. Recall #B-481-1.
CODE:
a) Unit 27GM22886, 27GX05539; b) unit 27GM22886, 27GX05539.
MANUFACTURER:
American Red Cross Blood Services, Johnstown Region, Johnstown, PA..
RECALLED BY:
Manufacturer, by letter on March 10, 2000. Firm-initiated recall 
complete.
DISTRIBUTION:
Pennsylvania.
QUANTITY:
Four units.
REASON:
Blood products, collected from a donor with a history of having tested 
positive for hepatitis, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-486-1; b) Platelets, Recall #B-487-1; c) 
Fresh Frozen Plasma. Recall #B-488-1;  Frozen Plasma.  Recall #B-489-1.
CODE:
a) Units 42FS55887, 42H19005, 42W11875; b) units 42FS55887,42H19005; c) 
units 42FS55887, 42H19005; d) unit 42W11875.
MANUFACTURER:
American Red Cross Blood Services, Northern Ohio Region, Cleveland , OH.
RECALLED BY:
Manufacturer, by letter dated August 8, 2000. Firm-initiated recall 
complete.
DISTRIBUTION:
Ohio.
QUANTITY:
Eight units.
REASON:
Blood products, collected from a donor with a history of having tested 
positive for hepatitis B core antigen (anti-HBc), were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-490-1; b)Recovered Plasma. Recall #B-491-1.
CODE:
a) Unit 04C25250; b)unit 04C25250.
MANUFACTURER:
American Red Cross, New England Region, Dedham, MA.
RECALLED BY:
Manufacturer, by telephone on May 24, 2000. And by letter dated June 5, 
2000.  Firm-initiated recall complete.
DISTRIBUTION:
New Hampshire.
QUANTITY:
Two units.
REASON:
Blood products, collected from a donor living with a father who had been 
diagnosed with hepatitis, were distributed.
________
PRODUCT:
a)Red Blood Cells, Recall #B-492-1; b) Recovered Plasma. Recall #B-493-1.
CODE:
a) Unit 09GN72421; b) unit 09GN72421.
MANUFACTURER:
American Red Cross Blood Services, Midwest Region, Omaha, NE.
RECALLED BY:
Manufacturer, by letters dated March 27 & 30, 2000. Firm-initiated recall 
complete.
DISTRIBUTION:
California.
QUANTITY:
Two units.
REASON:
Blood products, which tested negative for all required viral marker 
tests, but were collected from a donor who had previously tested positive 
for Hepatitis due to mononucleosis, were distributed.
________
PRODUCT:
Platelets, Recall #B-498-1.
CODE:
Unit 1696296.
MANUFACTURER:
Central Kentucky Blood Center, Lexington, KY.  
RECALLED BY:
Manufacturer, by letter dated October 24, 2000. Firm-initiated recall 
complete.
DISTRIBUTION:
Kentucky.
QUANTITY:
One unit.
REASON:
Blood producd, collected from a donor who had taken aspirin within 36 
hours of donation, was distributed.
________
PRODUCT:
Source Plasma. Recall #B-501-1.
CODE:
Unit 98AIAB4447.
MANUFACTURER:
Community Bio-Resources, Inc., Ames, IA.
RECALLED BY:
Manufacturer, by facsimile dated January l1, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
Austria.
QUANTITY:
One units.
REASON:
Blood products, collected from a donor who had been immunized with MMR 
vaccine, within four weeks of the donations, were distributed.
________
PRODUCT:
Source Plasma. Recall #B-502-1.
CODE:
Units 98AIAB3376, 98AIAB3604, 98AIAB4021.
MANUFACTURER:
Community Bio-Resources, Inc., Ames, IA.
RECALLED BY:
Manufacturer, by facsimile dated December 3, 1998. Firm-initiated recall 
complete.
DISTRIBUTION:
Austria.
QUANTITY:
Three units.
REASON:
Blood products, collected from a donor who had been immunized with MMR 
vaccine, within four weeks of the donations, were distributed.
________
PRODUCT:
Source Plasma for manufacture only into in vitro diagnostic reagents for 
which there are not alternative sources. Recall #B-515-1.
CODE:
Unit LO067455.
MANUFACTURER:
Sera-Tec Biological Limited Partnership, Loraine, OH.
RECALLED BY:
Manufacturer, by facsimile dated May 30, 2000. Firm-initiated recall 
complete.
DISTRIBUTION:
California.
QUANTITY:
One unit.
REASON:
Blood product, which tested RIBA anti-HCV positive, was distributed.
________
PRODUCT:
a)Red Blood Cells. Recall #B-518-1.  b) Red Blood Cells, Irradiated.  
Recall #B-519-1. 
CODE:
a) Units 27J51089, 27J51092, and 27J51090; b) unit 27J51095. 
MANUFACTURER:
The American National Red Cross, Greater Alleghenies Region, Johnstown, 
PA.
RECALLED BY:
Manufacturer, by letter dated February 2, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION:
Virginia.
QUANTITY:
Four units.
REASON:
Blood products, incorrectly tested for syphilis, were distributed.
________
PRODUCT:
Red Blood Cells. Recall #B-520-1.
CODE:
Unit 27J14201.
MANUFACTURER:
The American National Red Cross, Greater Alleghenies Region, Johnstown, 
PA.
RECALLED BY:
Manufacturer, by letter dated April 23, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
West Virginia.
QUANTITY:
One unit.
REASON:
Blood product, manufactured from an overweight unit of Whole Blood, was 
distributed.
________
PRODUCT:
a)Red Blood Cells. Recall #B-521-1; b) Platelets. Recall #B-522-1; c) 
Fresh Frozen Plasma.  Recall #B-523-1.
CODE:
a)Unit 0485059; b) pool number 0071372 (pool included single donor unit 
0485059); c) unit 0485059.
MANUFACTURER:
Hoxworth Blood Center, University of Cincinnati Medical Center, 
Cincinnati, OH.
RECALLED BY:
Manufacturer, by letters dated March 8, 2000 and June 5, 2000. Firm-
initiated recall complete.
DISTRIBUTION:
Ohio and Kentucky.
QUANTITY:
Three units.
REASON:
Blood products, collected from a donor who should have been deferred 
based on a reported blood/body fluid exposure, were distributed.
________
PRODUCT:
Red Blood Cells. Recall #B-524-1.
CODE:
Unit 27GS20999.
MANUFACTURER:
The American National Red Cross, Greater Alleghenies Region, Johnstown, 
PA.
RECALLED BY:
Manufacturer, by telephone on June 22, 1999. Firm-initiated recall 
complete.
DISTRIBUTION:
Pennsylvania.
QUANTITY:
One unit.
REASON:
Blood products, untested for Cytomegalovirus (CMV), but labeled as CMV 
negative, was distributed.
________
PRODUCT:
Source Plasma.  Recall #B-527-1.
CODE:
Units G-68267-099, G-65613-099, G-65277-099, G-64846-099, 
G-29146-099, G-28935-099, G-30131-099, and G-29970-099.
MANUFACTURER:
Alpha Therapeutic Corporation, Sacramento, CA.
RECALLED BY:
Manufacturer, by letter dated January 5, 2000. Firm-initiated recall 
complete.
DISTRIBUTION:
Tennessee, Italy, Spain, and Germany.
QUANTITY:
Eight units.
REASON:
Blood products, that tested negative for viral markers, but were 
collected from an unsuitable donor tbased on previous reactive viral 
marker testing, were distributed.
________
PRODUCT:
Platelet, Pheresis, Leukocytes Reduced.  Recall #B-528-1.
CODE:
Unit 12W40418.
MANUFACTURER:
American National Red Cross Services, The Carolina Region, Charlotte, NC.
RECALLED BY:
Manufacturer, by telephone on January 28, 2000.  Firm-initiated recall 
complete.
DISTRIBUTION:
North Carolina.
QUANTITY:
One unit.
REASON:
Blood product, with elevated platelet count, was distributed.

END OF ENFORCEMENT REPORT FOR FEBRUARY 14, 2001

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