Contaminated Antiseptic Products Recalled

Antiseptic sterile skin products manufactured by Clinipad Corp. of Rocky Hill, Conn., were voluntarily recalled by the company in March because they could be contaminated by bacteria that cause serious--even life-threatening--skin, wound, or other infections. The products are frequently used at blood collection centers.

There have been no known instances of blood contamination traceable to the recalled products; however, the company confirmed bacterial contamination in some lots of its sterile products, one of which was recalled in December 1999, and could not assure the sterility of other products labeled and sold as sterile.

The swabsticks, prep pads, towelettes, ointments, pouches, and dressings are distributed under the tradenames Cliniswab, Clinipad, Clinidine, Cliniguard, EZ Prep, Cooper Instrument Corp., Moore Medical Corp., and Rauscher. Sold separately or packed in kits, they were distributed to blood banks, hospitals, clinics and retail pharmacies. Products in the recall were manufactured from January 1, 1997, to the time of the recall and include povidone iodine, tincture of iodine, benzoin tincture, acetone alcohol, and alcohol antiseptic products as well as Sterile Cliniguard Protective Dressing.

Products in the recall are labeled "sterile" or "sterile unless opened or damaged." They have lot numbers beginning with 7,8,9, or 0. Health professionals and consumers who have products with these lot numbers should destroy them.

Consumers and health professionals can get more information about the recall on the World Wide Web at www.fda.gov/medwatch. To help blood collection centers develop alternative skin preparations, FDA has also posted information on www.fda.gov/cber/infosheets.htm and www.fda.gov/cber/recalls.htm.> Clinipad Corp. has sent recall notices to 3,000 customers and 100 kit manufacturers. Consumers with questions may contact the Clinipad Corporation at 860-571-0100.