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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 64373
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 2010-12-22
Initial Firm Notification of
Consignee or Public
Distribution Pattern Michigan; Nebraska; Florida; California; Kentucky

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Tendon UBI009136012610; UBI009136012710; UBI009136012810; UBI009136012910; UBI009136013110; UBI009136013210; UBI009136013310; UBI009136013410 Class III HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. 8 B-1132-13