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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Event Detail

Event ID 68055
Product Type Biologics
Status Terminated
Recalling Firm Oklahoma Blood Institute - Sylvan N Goldman Center
City Oklahoma City
State OK
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-05
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern TX, OK

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced Irradiated 4662137 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 1 unit B-0647-14
Red Blood Cells Leukocytes Reduced W091010144602; W091009168622 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 2 units B-0646-14
Platelets Pheresis Leukocytes Reduced W091010301993; W091010301993 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 2 units B-0645-14
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