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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Withdrawal of Human Tissue Products-Lost Mountain Tissue Bank

DATE WITHDRAWAL INITIATED:

October 10, 2005

PRODUCT:

Human Tissue for Transplantation

MANUFACTURER:

Lost Mountain Tissue Bank
Kennesaw, Georgia

REASON:

Lost Mountain Tissue Bank, Inc. (LMTB) has initiated consignee notifications for all tissue products processed and/or distributed from donors procured in the New York area by Biomedical Tissue Services (BTS; Ft. Lee, New Jersey). LMTB was informed of some discrepant and possibly fraudulent information in donor documentation. LMTB is notifying all relevant hospitals and medical professionals of the market withdrawal of all tissue products beginning with the letters “GL” or “T” in the tissue identification number (ID#).

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002