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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 66649
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Switzerland, Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Recovered Plasma W036809346147 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-0201-14
Platelets Pooled Leukocytes Reduced W036809824342 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-0200-14
Red Blood Cells W036809346147 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-0199-14
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