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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Human Tissue Products-Regeneration Technologies, Inc

DATE RECALL INITIATED:

October 14, 2005

PRODUCT:

Human Tissue For Transplantation

MANUFACTURER:

Regeneration Technologies, Inc
Alachua, Florida

REASON:

Regeneration Technologies, Inc. (RTI) is conducting a voluntary recall of all tissue received from BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) as a result of information regarding the accuracy of donor screening documentation. RTI informed its consignees that a lack of assurance of donor identity as well as the risk of infectious diseases also exists. Consignees are asked to contact the manufacturer to arrange for product return.

 

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