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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Event Detail

Event ID 62722
Product Type Biologics
Status Terminated
Recalling Firm Suncoast Communities Blood Bank, Inc.
City Sarasota
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-18
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Korea, Republic Of(South); Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W038611816953; W038611815574; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 2 B-2554-12
Cryoprecipitated AHF W038611816953; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 1 B-2555-12
Blood and Blood Products for Reprocessing W038611816953; W038611815574; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 2 B-2556-12
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