WASHINGTON, April 20 (UPI) — The U.S. Food and Drug Administration says an Ohio company has agreed to stop selling unapproved and misbranded sterilization devices.
The FDA said a consent decree filed against the Steris Corp. of Mentor, Ohio, stops the firm from distributing the devices that are used to sterilize heat-sensitive instruments and medical devices. It prohibits the distribution of the Steris System 1 Processor, or SS1 — a tabletop liquid chemical system marketed to disinfect certain devices, such as endoscopes, that cannot withstand steam sterilization.
In May 2008 the FDA advised the company that significant changes it made to the SS1 caused the device to be adulterated and misbranded.
Under the consent decree, the FDA said Steris agreed to destroy used SS1 devices, although some specified unused devices and components can, with FDA approval, be retained.
A updated system produced by Steris, the SS1E, has been approved by the FDA as a liquid chemical sterilant processing system.
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