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SafetyAlerts
March 30, 2000

Prepackaged Procedure Kits and Trays May Contain Recalled Clinipad Products

Pleasanton, CA (SafetyAlerts) - In a letter to healthcare proffessionals, Clinipad Corporation has announced that certain prepackaged procedure kits and trays may include sterile antiseptic skin preparations that have been recalled because they may not be sterile. More than 140 manufacturers prepare a variety of procedure kits and trays that include one or more of these recalled products.  Click here to view the Clinipad recall.

Clinipad has issued the following reccomendations:

  • Do not use any recalled Clinipad Corporation 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.

Clinipad Corporation Products Included in the Recall

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."  Click on a link below for the list of recalled items.
Sterile
Non-sterile

The recall includes all such products manufactured since January 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.

Reason for the Recall

The reason for the Clinipad Corporation recall is that the company has confirmed bacterial contamination in some lots of its sterile products, including one lot with Pseudomonas aeruginosa, Stenotrophomonas maltophilia, and coagulase negative Staphylococcus, and therefore cannot assure the sterility of its 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.

Additional Information

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 is http://www.fda.gov/cber/infosheets.htm.

The Clinipad Corporation can be contacted at 860-571-0100.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.