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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Human Tissue Products-LifeCell Corp

DATE RECALL INITIATED:

September 30, 2005

PRODUCT:

AlloDerm, Repliform, and GraftJacket

MANUFACTURER:

LifeCell Corporation
Branchburg, New Jersey

REASON:

LifeCell Corporation initiated a voluntary recall of certain AlloDerm, Repliform, and GraftJacket product from the marketplace on September 30, 2005. The recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization. Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS). Life Cell promptly notified the FDA and all relevant hospitals and medical professionals. All other BTS inventory remains on hold until the discrepancies in the donor documentation can be resolved. LifeCell works with more than 40 other tissue recovery organizations that are not affected by this recall.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448