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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Event Detail

Event ID 65867
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Miami
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-19
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 (Apheresis) W036809423169; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-2521-13
Red Blood Cells(Apheresis) W036809423169; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-2522-13
Platelets Pheresis Leukocytes Reduced W036809423169; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 B-2523-13
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