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Facilities Must Stop Using Custom Ultrasonics' System To Reprocess Duodenoscopes, FDA Warns

 
• By Sue Darcey

The US agency issued a safety communication Aug. 17 advising all health care facilities to stop using Custom Ultrasonics' System 83 Plus automated endoscope reprocessors to reprocess duodenoscopes, although facilities may continue to use the AERs to clean and sterilize other flexible endoscopes.

FDA urged all health-care facilities and health-care providers that perform endoscopic procedures to cease using Custom Ultrasonics Inc.'s System 83 Plus reprocessors on duodenoscopes in an Aug. 17 safety communication. The safety warning comes on the heels of the company's May 6 voluntary "urgent medical device recall" of the units for use with duodenoscopes, a recall that covers the company's System 83 Plus 2 and the System 83 Plus 9 AERs, also.

In an unusual November 2015 recall order, FDA had asked health care facilities to find alternate methods to clean and sterilize (reprocess) all flexible endoscopes with Custom Ultrasonics' AERs under...

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