FDA orders recall of Custom Ultrasonics automated endoscope reprocessors
The recall is the result of violations committed by Ultrasonics since 2007. The violations, an FDA representative said, could mean an increased risk of the transmission of infections. The FDA has advised all health care facilities using the Custom Ultrasonics AERs to find other ways to reprocess flexible endoscopes.
It is estimated that 2,800 of these AERs are in use across the U.S.
“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said. “The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health.”
AERs are used to wash and decontaminate high-level endoscopes.
Custom Ultrasonics received a notice from the FDA in 2012 demanding the company stop the production and distribution of all AER device models and components. The items were recalled when Ultrasonics did not get FDA clearance after making changes to the software system for one of its AERs. Once the company obtained FDA clearance, they were able to keep the devices on the market.
The most recent recall came after FDA officials visited a Custom Ultrasonics facility in April 2015 and continued violations were reported.
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