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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
E-Mail
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
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