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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 65534
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-10
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern FL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fresh Frozen Plasma W036811019372 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2271-13
Red Blood Cells W036811019372 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2270-13
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