May 9, 2016

FDA drops recall of Custom Ultrasonics’ System 83 Plus endoscope reprocessor

Editor's Note

The Food and Drug Administration (FDA) has dropped its recall of approximately 2,800 Custom Ultrasonics’ System 83 Plus automated endoscope reprocessors. This action comes despite the FDA's finding last year that the recall was “necessary to protect public health,” the May 6 Kaiser Health News reports.

The FDA now says the System 83 Plus can remain in the field while regulatory issues are being addressed, but the reprocessors still cannot be used to disinfect duodenoscopes.

 

The Food and Drug Administration has dropped a recall of some 2,800 scope-cleaning machines in use at hospitals and clinics nationwide despite a finding by a top agency scientist last year that the action was "necessary to protect public health."

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