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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description Human Skin for Transplant
Recall Number B-1579-12
Classification Class II
Code Info NLGIN100003001, NLGIN100003002, NLGIN100003003, NLGIN100003004, NLGIN100003005, NLGIN100003006, NLGIN100003007, NLGIN100003008, NLGIN100003009, NLGIN100003010, NLGIN100003011, NLGIN100003012, NLGIN100003013, NLGIN100003014, NLGIN100003015, NLGIN100003016, NLGIN100003017, NLGIN100003018, NLGIN100003019, NLGIN100003020, NLGIN100003021
Product Distributed Qty 21
Reason For Recall Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.

Event Detail

Event Id 59719
Product Type Biologics
Status Ongoing
Recalling Firm New Life Generation, INC.
City Indianapolis
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern IN, CA, VA