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SAFETY ALERT ISSUED FOR MEDICAL EQUIPMENT CLEANING DEVICES

September 1, 2006

The FDA and Steris have issued a MedWatch safety alert for two devices used to clean reusable medical equipment.

The firm has notified hospital and long-term care facility managers of a fire risk from the use of Amsco Sonic Energy Cleaners and Consoles manufactured from November 2000 until January 2005. A total of 675 units have been recalled.

"The location of the lid switch cable wiring harness in these units makes them susceptible to water damage to the electrical connections," Steris said in a June 21 product correction notice. This can cause overheating of the electrical system in the unit and lead to damage of the wiring harness, resulting in smoking, sparking and fire, the firm said.

A Steris technician will replace the wire harness and associated components of the affected units, the firm said. In the meantime, users should prevent water from contacting the electrical wiring while using the device.

The Steris product correction notice can be viewed at www.fda.gov/medwatch/safety/2006/Steris_letter.htm (http://www.fda.gov/medwatch/safety/2006/Steris_letter.htm).