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U.S. Department of Health and Human Services

Animal & Veterinary

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NATIONWIDE RECALL OF CLINIPAD ANTISEPTIC STERILE PRODUCTS

FDA Veterinarian Newsletter May/June 2000 Volume XV, No III

On March 10, 2000, FDA announced that Clinipad Corp. of Rocky Hill, Connecticut, initiated a voluntary recall of its antiseptic sterile skin preparations because of a potential for bacterial contamination. The company had confirmed bacterial contamination in some lots of its sterile products, including one lot with Pseudomonas aeruginosa and Stenotrophomonas maltophilia (recalled in December 1999), and therefore, cannot assure the sterility of products labeled and sold as sterile.

These organisms can cause skin, wound, or other infections that may be serious or life-threatening in some cases.

The nationwide recall of the Clinipad sterile-products line includes Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol and Alcohol Antiseptic Products, as well as Sterile Cliniguard Protective Dressing Labeled as "sterile," manufactured since Jan. 1, 1997. The products (swabsticks, prep pads, towelettes, ointments and pouches, as well as 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 institutional kits and are widely distributed to blood banks, hospitals, clinics, and retail pharmacies and are used to control and prevent infection.

All lots of the sterile products line involved in the recall have a lot number beginning with 7, 8, 9, or 0, and are labeled as "sterile" on the unit of use packaging, or "sterile unless opened or damaged." The lot numbers are also found on the shipping carton or its label.

Health professionals and consumers who have these products can obtain more information about the recall from FDA's MedWatch Website. Also, consumers with questions may contact the Clinipad Corporation at 860-571-0100.