On Feb. 23, the Food and Drug Administration reaffirmed its recall of Custom Ultrasonic's automated endoscope reprocessors. The initial recall order was issued in November 2015. Subsequently Custom electronics submitted a recall strategy, which the FDA found inadequate.
The FDA asserts that Custom Ultrasonics failed to demonstrate that its AERs can effectively wash and disinfect endoscopes for the purpose of mitigating risk of patient infection. The agency recommends that all healthcare facilities using Custom Ultrasonic's AERs begin to transition to alternative reprocessing methods for their flexible endoscopes as soon as possible.
The agency has also warned the company that if they do not comply with the orders of the recall they may seek the legal remedies of the court, including, but not limited to, civil or criminal contempt.
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