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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Event Detail

Event ID 65087
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 2013-02-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern Greece

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fascia 0087040077 Class II Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed. 1 allograft B-1747-13