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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62411
Product Type Biologics
Status Terminated
Recalling Firm South Texas Blood & Tissue Center
City San Antonio
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-03
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Austria, Florida, Texas

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plasma Frozen Cryoprecipitated Reduced 2487825 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 1 unit B-2114-12
Cryoprecipitated AHF, Pooled 2424507, 2487825 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 2 units B-2115-12
Fresh Frozen Plasma 2590622, 2699615, 2522388 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 3 units B-2116-12
Recovered Plasma 2386094, 2424507, 2459485, 2613407, 2555602 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 5 units B-2117-12
Red Blood Cells Leukocytes Reduced 2386094, 2424507, 2459485, 2487825, 2522388, 2555602, 2590622, 2699615 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 8 units B-2118-12
Red Blood Cells (Apheresis) Leukocytes Reduced 6325565 (2 units) Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 2 units B-2119-12
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