FDA orders recall of endoscope reprocessors

FDA orders company to recall automated endoscope reprocessors
The Food and Drug Administration (FDA) ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a consent decree entered with the company in 2007.

The FDA’s most recent inspection of Custom Ultrasonics' facility in April 2015 documented continued violations, including the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. In the months following the inspection, the FDA provided the company with an opportunity to correct inspection violations and requested additional validation data. Following a review of the company’s submissions, the agency determined that Custom Ultrasonics had not adequately addressed its continued violations, which could result in an increased risk of infection transmission to patients.

An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. The FDA’s recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9.

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