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Recall of Human Tissue Products

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DATE RECALL INITIATED:

    October 12, 2005

PRODUCT:

    Human Tissue for Transplantation

MANUFACTURER:

    Tutogen Medical, Inc.
    Alachua, Florida

REASON:

    Tutogen Medical is conducting a voluntary recall of all materials that were manufactured utilizing BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) donor tissue. This action is being taken because Tutogen is unable to satisfactorily confirm that donor eligibility had been properly obtained by BTS. Tutogen informed its consignees that there is a lack of assurance that appropriate donor identification, donor screening, and medical history data collection was performed and, therefore, a risk of infectious disease exists. Consignees are asked to contact the manufacturer to arrange for product return.

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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.

 

Updated October 18, 2005
 
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