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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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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
Distribution Pattern Indiana

Product Detail

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