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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 62064
Product Type Biologics
Status Terminated
Recalling Firm Blood Centers of the Pacific - Irwin Center
City San Francisco
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-09
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Switzerland; Austria; California

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W117009159701N; W117009125131Y; W117009194370I; W117011426472Y; W1170101117358; W117011455152N; W1170114417093; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. 7 units B-1947-12
Fresh Frozen Plasma W117009194370I; W117009125131Y; W117011426472Y; W1170101117358; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. 4 units B-1946-12
Blood and Blood Products for Reprocessing W117010196924W; W1170114417093; Class III Blood products, collected from a donor with a history reactive results for HCV, were distributed. 2 units B-1945-12
Cryoprecipitated AHF, Pooled W117009159701N; W117010100874Y; W1170114435834; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. 3 units B-1944-12
Plasma Frozen W117011455152N; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. 1 unit B-1943-12
Red Blood Cells Leukocytes Reduced Irradiated W117010196924W; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. 1 unit B-1942-12
Plasma Frozen Cryoprecipitated Reduced W117009159701N; Class II Blood products, collected from a donor with a history reactive results for HCV, were distributed. 1 unit B-1941-12
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