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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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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
Distribution Pattern New York

Product Detail

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