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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65199
Product Type Biologics
Status Terminated
Recalling Firm Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc
City Tyler
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern Texas

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) Leukocytes Reduced W035212218081F(Part A); W035212218081F(Part B) Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 units B-2000-13