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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Bone
Recall Number B-0124-14
Classification Class I
Code Info 0108090073; 0108090075; 0108090076; 0108090077; 0108090078; 0108090106; 0108090107; 01080900108; 0108090109; 0108090074
Product Distributed Qty 10 allografts
Reason For Recall Tissue allografts, associated with positive pre-processing cultures for Clostridium, were distributed.

Event Detail

Event Id 66770
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 2013-07-24
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Florida; New York