Clinipad Recalls Procedure Kits

<%=company1%> (Rocky Hill, CT) has issued a recall of certain prepackaged procedure kits and trays because sterile antiseptic skin preparations may not be sterile. More than 140 manufacturers prepare a variety of procedure kits and trays that include one or more of these recalled products.

The nationwide recall includes povidone iodine, tincture of iodine, benzoin tincture, acetone alcohol and alcohol antiseptic products, as well as Sterile Cliniguard protective dressing labeled as "sterile." The recall includes all such products manufactured since January 1, 1997.

The products (swabsticks, prep pads, towelettes, ointment tubes and pouches, and protective dressings) are distributed under the names Cliniswab, Clinipad, Clinidine, Cliniguard, EZ Prep, Cooper Instrument Corp., Moore Medical Corp., and Rauscher. They are sold separately or packaged in various manufacturer-prepared procedure kits and trays and are widely distributed to blood banks, hospitals, clinics, and retail pharmacies. They are used to prepare the skin prior to invasive procedures.

Clinipad has confirmed bacterial contamination in some lots of its sterile products, including one lot with Pseudomonas aeruginosa, Stenotrophomonas maltophilia, and coagulase negative Staphylococcus, and therefore cannot assure the sterility of its products labeled and sold as sterile.

For more information, visit FDA's website at http://www.fda.gov/medwatch/safety/2000/safety00.htm or contact Clinipad at 860-571-0100.

Edited by Ursula Jones