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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description Tendon
Recall Number B-0048-14
Classification Class II
Code Info 0086580059
Product Distributed Qty 1 allograft
Reason For Recall Human tissue allograft, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, was distributed.

Event Detail

Event Id 66153
Product Type Biologics
Status Terminated
Recalling Firm University Of Miami Miller School of Medicine Tissue Bank
City Miami
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Indiana
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