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Withdrawal of Human Tissue Products

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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#).

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

 
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