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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 Decellularized Dermis (Skin, human tissue for transplantation), product codes AFLEX100, AFLEX101, DCELL102, DCELL200, and DCELL251
Recall Number B-0350-13
Classification Class II
Code Info Serial numbers: 1012784D190, 1012784D191, 1012784D192, 1012784D193, 1012784D194, 1012784D195, 1012784D196, 1012784D197, 1012784D198, 1012784D199, 1012784D200, 1012784D201, 1012784D202, 1012784D212, 1012784D213, 1012784D214, 1012784D218
Product Distributed Qty 17 tissues
Reason For Recall Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.

Event Detail

Event Id 62610
Product Type Biologics
Status Completed
Recalling Firm LifeNet Health
City Virginia Beach
State VA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern The tissues were shipped nationwide and to Canada and Korea.
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