In March 2000, the Food and Drug Administration announced that Clinipad Corp. of Rocky Hill, Conn., was voluntarily recalling antiseptic sterile skin preparations because of a potential for bacterial contamination. The reason for the recall was that the company 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 could not assure the sterility of products labeled and sold as sterile.
These organisms can cause skin
, or other infections
that may be serious or life-threatening in some cases.
The nationwide recall of the Clinipad sterile-products line included 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) were distributed under the names: Cliniswab, Clinipad, Clinidine, Cliniguard, EZ Prep, Cooper Instrument Corp., Moore Medical Corp., and Rauscher. They were sold separately or packaged in various institutional kits and were widely distributed to blood banks, hospitals, clinics, and retail pharmacies and were used to control and prevent infection.
In addition to other medical uses, these products were used to prepare the skin prior to the collection of blood or plasma donations. 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 had a lot number beginning with 7, 8, 9, or 0, and were labeled as "sterile" on the unit of use packaging, or "sterile unless opened or damaged." The lot numbers were also found on the shipping carton or its label.
Clinipad Corp. sent recall notices to 3,000 customers and 100 kit manufacturers. These customers were advised to examine stocks and remove the recalled products, including products in kits, and to promptly destroy them.
After the recall, Clinipad's plant in North Carolina was shut down and the company was forced out of business.
See your doctor if you were injured by a Clinipad Antiseptic Sterile Product. In addition, it may be important to contact an attorney
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