Custom Ultrasonics System 83 Plus Washer/Disinfector System 83 Plus Mini-flex Washer/Disinfector

Published: Wed Feb 07 00:00:00 -0500 2007

FDA informed healthcare professionals that Custom Ultrasonics agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System 83 Plus Mini-flex Washer/Disinfector, used to wash and disinfect flexible endoscopes, until it brings its manufacturing methods and controls into compliance with FDA requirements. Endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life threatening infections. FDA advised health care providers to discontinue using these products, using an alternative device or following appropriate protocols to manually wash and disinfect the device.