Medical Device Co. Pulls Endoscopes

Law360, New York (February 8, 2007, 12:00 AM EST) -- After repeated violations found during U.S. Food and Drug Administration inspections, medical device maker Custom Ultrasonics has agreed to stop selling two manufacturing devices that wash and disinfect endoscopes.

The company agreed to a consent decree on Jan. 25, but said Wednesday it would no longer market its System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector until it brings the methods and controls used to manufacture the devices into compliance with FDA's Current Good Manufacturing Practice requirements of its Quality System (QS) regulation....
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