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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 67954
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Lauderhill
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-31
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern NY, FL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pooled Leukocytes Reduced 2906908 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0607-14
Fresh Frozen Plasma 2365399 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0606-14
Red Blood Cells 2365399 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0605-14
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