WASHINGTON, March 10, 2000
The Food and Drug Administration today announced that Clinipad Corp. of Rocky Hill, Conn., is voluntarily recalling antiseptic sterile skin preparations because of a potential for bacterial contamination.
The reason for the recall is that the company has 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.
In addition to other medical uses, these products are used to prepare the skin prior to the collection of blood or plasma donations. Although there have been no known instances of blood contamination traced to the recalled products, clinicians should remain alert to this possibility.
Contamination of blood collections with bacteria from the skin contributes to rare bacterial infections from transfusions. Serious bacterial infections occur in approximately 1 out of 50,000 to 1 out of 500,000 transfusions, depending on the exact blood product administered. Recent data from CDC have shown no increase in bacterial contamination of transfused blood products over a two-year period.
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.
Clinipad Corp. is sending recall notices to 3,000 customers and 100 kit manufacturers. These customers are being advised to examine stocks and remove the recalled products, including products in kits, and to promptly destroy them. Health professionals and consumers who have the product with the involved lot numbers should destroy the product.
To assist blood collection centers in developing alternative skin preparations, the Food and Drug Administration, Center for Biologics Evaluation and Research, has posted information on its Websites at www.fda.gov/cber/infosheets.htm and www.fda.gov/cber/recalls.htm. The sites identify alternative products and procedures that can be used at donor centers.
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.