FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

FDA Issues More Warnings on Custom Ultrasonics Reprocessors for Duodenoscopes

Aug. 23, 2016
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The FDA is recommending that health care facilities stop using an endoscope reprocessor system from Custom Ultrasonics to disinfect duodenoscopes.

The warning covers all Custom Ultrasonics’ System 83 Plus Automated endoscope reprocessors but notes that the reprocessors may be used to reprocess other flexible endoscopes, just not duodenoscopes.

The communication was triggered by an urgent medical device recall that Custom Ultrasonics issued in May advising users to stop using its System 83 Plus AERS for duodenoscopes. As part of the recall, the company is providing customers with a label to affix on the reprocessors warning that they are not indicated for reprocessing duodenoscopes.

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