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U.S. Department of Health and Human Services

Safety

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

Audience: Hospital risk managers, nursing supervisory staff

[UPDATE 02/27/2007] FDA issued a Public Health Notification to further inform hospitals and other user facilities about FDA’s action, and to provide recommendations for facilities currently using the affected products.

[Posted 02/07/2007] 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.

[February 27, 2007 – Public Health Notification – FDA]
[February 07, 2007 – News Release – FDA]