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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Event Detail

Event ID 65346
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-02
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fresh Frozen Plasma 2565869; Class II Blood products, collected from an inelgibile donor, were distributed. 1 unit B-2230-13
Platelets Pooled Leukocytes Reduced 2922847; Class II Blood products, collected from an inelgibile donor, were distributed. 1 unit B-2231-13
Red Blood Cells 2565869; 2514057; Class II Blood products, collected from an inelgibile donor, were distributed. 2 units B-2232-13
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