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).

According to a company release, LifeCell 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.

“While no adverse events have been reported we took this prudent and precautionary measure because LifeCell is committed to patient safety and quality,” stated Paul G. Thomas, Chairman of the Board, president and chief executive officer for LifeCell.

The release added, if the company is unable to resolve the questions regarding donor documentation, it would not distribute the BTS inventory. The inability to distribute this product would result in a charge to operating income of approximately $1.5 million.

LifeCell develops and markets products made from human tissue for use in reconstructive, orthopaedic and urogynecologic surgical procedures. The company's patented technology produces a unique regenerative human tissue matrix —a complex three-dimensional structure that contains an array of proteins, growth factor binding sites and vascular channels —that provides a complete template for the regeneration of normal human tissue.