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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Source Plasma
Recall Number B-2058-12
Classification Class III
Code Info 0630042647;
Product Distributed Qty 1
Reason For Recall Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

Event Detail

Event Id 61887
Product Type Biologics
Status Terminated
Recalling Firm Biomat USA, Inc.
City Salt Lake City
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-01-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern California
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