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***" |
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| 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. |
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