FDA issues alert on recalled skin preps

Bacterial contamination found in some lots

Infection control professionals should be aware that certain prepackaged procedure kits and trays may include sterile antiseptic skin preparations that are contaminated, the Food and Drug Administration is advising. Clinipad Corp. of Rocky Hill, CT, has confirmed bacterial contamination in some lots of its sterile products, which have been recalled. One lot was contaminated with Pseudomonas aeruginosa, Stenotrophomonas maltophilia, and coagulase-negative Staphylococcus.

As ICPs are well aware, these organisms can cause skin, wound, or other infections that may be serious or life-threatening in some cases. More than 140 manufacturers prepare a variety of procedure kits and trays that include one or more of these recalled products. David W. Feigal Jr., MD, MPH, director of the FDA Center for Devices and Radiological Health, issued the following recommendations and details in a advisory date March 29, 2000:

• Do not use any recalled Clinipad Corp. products.

• You should be receiving Urgent Device Recall letters from the manufacturers of affected procedure kits and trays used in your facility. Each manufacturer may handle the recall of their kits and trays differently. Follow the directions provided by each manufacturer for their kits and trays. Even if the kit or tray manufacturer does not contact you, you still should not use any of the recalled Clinipad products.

• Keep in mind that unless stated otherwise by the manufacturer, only the Clinipad product from each kit or tray is being recalled.

• If you assemble custom kits for use in your facility, be sure to remove all recalled products from these kits.

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." The recall includes all such products manufactured since Jan. 1, 1997. The products (swabsticks, 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.

They are sold separately or packaged in various manufacturer-prepared procedure kits and trays and are widely distributed to blood banks, hospitals, clinics, and retail pharmacies. They are used to prepare the skin prior to invasive procedures.

All lots of the sterile products involved in the recall have a lot number beginning with 7, 8, 9, or 0, and are labeled as "sterile" or "sterile unless opened or damaged" on the unit of use packaging.

For facilities whose current procedure includes the use of the recalled prepackaged products, FDA’s Center for Biologics Evaluation and Research has posted information on its Web site regarding methods and products that may be used for skin preparation prior to the collection of blood and blood components. The Web address for this information is http://www.fda. gov/cber/infosheets.htm.

The FDA reminds that ICPs and other clinicians can help in collecting data on adverse events related to medical devices. ICPs can report incidents directly to MedWatch, the FDA’s voluntary reporting program. The reports can be submitted by phone at (800) FDA-1088; by fax at (800) FDA-0178; via the MedWatch Web site at http://www.fda.gov/medwatch; or by mail to MedWatch, FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.

[Editor’s note: Additional information regarding the recall can be found on the FDA’s MedWatch Web site at http://www.fda.gov/medwatch/safety/2000/safety00.htm. The Clinipad Corp. can be contacted at (860) 571-0100. Questions regarding the FDA letter can be sent via e-mail to [email protected]; faxed to Marian Zelda at (301) 594-2968; or submitted in writing to Zelda at FDA, CDRH, Office of Surveillance and Biometrics, HFZ-510, 1350 Piccard Drive, Rockville, MD 20850. Additional copies of the notification can be found on the FDA Web site at http://www.fda.gov/cdrh/ safety.html.]