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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

Product Description Ultrafill DBM Human is labeled in part: "***Tissue ID:***Description: Ultrafill DBM Human***Size 10cc***Product Code HM53010***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T10^6 (r)minal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***Ultrafill DBM Human***HM53010 EXP:***TissueNet 800-465-8800***"
Recall Number B-1640-12
Classification Class II
Code Info Product ID: TN4211610093, TN4211610094, TN4211610095, TN4211610096, TN4211610097
Product Distributed Qty 5 ea
Reason For Recall Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.

Event Detail

Event Id 60076
Product Type Biologics
Status Ongoing
Recalling Firm Surgical Tissue Network, Inc. dba TissueNet
City Orlando
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Products were distributed to NJ, TX, NH, NY, PR; and to Turkey, Korea, and Chile.