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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Event Detail

Event ID 64955
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 2013-02-06
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Texas

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) Leukocytes Reduced 7188318; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 1 B-1772-13
Platelets Pheresis Leukocytes Reduced Irradiated 7188318; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 1 B-1773-13
Fresh Frozen Plasma W140912138630; 2488230; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 2 B-1774-13
Red Blood Cells Leukocytes Reduced W140912138630; 2488230; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 2 B-1775-13
Platelets 2488230; Class III Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. 1 B-1776-13
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