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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Event Detail

Event ID 67571
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Lauderhill
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-28
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Florida

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pooled Leukocytes Reduced W036813817523, 2909442 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 2 units B-0482-14
Red Blood Cells W036813023947, 2300334 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 2 units B-0481-14
Red Blood Cells Leukocytes Reduced W036813256009 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-0480-14
Plasma Frozen within 24 hours (FP24) W036813256009 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-0479-14
Blood and Blood Products for Reprocessing W036813023947 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-0478-14
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