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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 67693
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-03
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern New York; Switzerland

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W036808110290; Class II Blood products, collected from a donor whose suitability to donate was not fully evaluated, was distributed. 1 unit B-0501-14
Blood and Blood Products for Reprocessing W036808110290; Class III Blood products, collected from a donor whose suitability to donate was not fully evaluated, was distributed. 1 unit B-0500-14
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