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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 66615
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-24
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern FL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 1511568 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-0122-14
Red Blood Cells Leukocytes Reduced Irradiated 1481439; 1511452 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 2 units B-0121-14
Platelets Leukocytes Reduced 1481439 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-0120-14
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