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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description Cardiac Tissue, Non-valved
Recall Number B-2097-13
Classification Class II
Code Info 083696HV02
Product Distributed Qty 1 allograft
Reason For Recall Cardiac pulmonary patch, recovered from a donor and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed.

Event Detail

Event Id 65437
Product Type Biologics
Status Terminated
Recalling Firm LifeNet Health
City Virginia Beach
State VA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Massachusetts