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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 5cc***Product Code HM53005***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***HM53005 EXP:***TissueNet 800-465-8800***"
Recall Number B-1641-12
Classification Class II
Code Info Product ID: TN4211610098, TN4211610099, TN4211610100, TN4211610101, TN4211610102, TN4211610103, TN4211610104, TN4211610105, TN4211610106, TN4211610107
Product Distributed Qty 10 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.