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Some Sterile Antiseptic Skin Preparations Found Not Sterile
ROCKVILLE, MD-The Center for Devices and Radiological Health is alerting hospitals that the Clinipad Corporation is sending out urgent device recall letters regarding their sterile-products line including Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol, Alcohol Antiseptic Products, and Sterile Cliniguard Protective Dressing labeled as "sterile." The recall was prompted by the discovery of bacterial contamination in some lots of Clinipad's sterile products. All of the lots involved in the recall have a lot number beginning with seven, eight, nine, or zero, and are labeled as "sterile" or "sterile unless opened or damaged." The products (swab sticks, 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. The recall includes all such products manufactured since January 1, 1997.
Please contact the Clinipad Corporation at (860) 571-0100 for further information.