Clinipad recalls contaminated products
No injuries or complaints reported
The Clinipad Corp. in Rocky Hill, CT, is voluntarily recalling all povidone-iodine, tincture of iodine, benzoin tincture, acetone alcohol, and alcohol antiseptic products (swabsticks, prep pads, towelettes, and pouches), and Cliniguard protective dressings labeled as "sterile" that were manufactured in the last three years, according to a March 9 letter from Nelson M. Ford, president and CEO of Clinipad. The letter can be viewed at www.fda.gov/medwatch/safety/2000/clinip.htm and the complete list of products at www.fda.gov/ medwatch/safety/2000/clinip1.htm.
The company made this voluntary recall due to confirmed microbial contamination in some lots of its sterile products, including one lot with Pseudomonas aeruginosa, Stenotrophomonas maltophilia, and coagulase-negative Staphylococcus, which was recalled in December 1999. While Clinipad has received no confirmed reports of patient complaints or injuries as a result of contamination of these products, the potential for microbial contamination exists, and the company is unable to assure the sterility of products labeled and sold as sterile. Nonsterile products appearing on the recall list also are being recalled because the company cannot assure the products meet their microbial release specifications.
Advice to professionals
A March 29 letter from David W. Feigal Jr., MD, MPH, director of the Center for Devices and Radiological Health, advised health professionals that prepackaged procedure kits and trays may include some of the above-mentioned recalled products from Clinipad. More than 140 manufacturers prepare a variety of procedure kits and trays that include one or more of the Clinipad products.
The Food and Drug Administration’s Center for Biologics Evaluation and Research has posted information regarding methods and products that may be used for skin preparation prior to the collection of blood and blood components. This information is available at www.fda.gov/cber/ infosheets.htm. The Clinipad Corp. can be reached at (860) 571-0100.
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