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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Event Detail

Event ID 65750
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Lantana
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-17
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
Red Blood Cells W036813024156; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-2472-13
Fresh Frozen Plasma W036813024156; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-2471-13
Platelets Pooled Leukocytes Reduced W036812853139; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-2470-13
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