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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description Cardiac Tissue, Non-valved
Recall Number B-0386-13
Classification Class II
Code Info 11112910004
Product Distributed Qty 1
Reason For Recall Cardiac Tissue Allograft, processed in a manner that did not prevent the introduction, transmission, or spread of communicable disease, was distributed.

Event Detail

Event Id 63427
Product Type Biologics
Status Terminated
Recalling Firm LifeNet Health
City Virginia Beach
State VA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-26
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern New York