News

FDA issues update on recalled Custom Ultrasonics endoscope reprocessors

Following Custom Ultrasonics’ Urgent Medical Device Recall it sent to customers May 6, the Food and Drug Administration (FDA) is advising users to stop using the manufacturer’s System 83 Plus AERs for reprocessing of duodenoscopes. The notice revises the FDA’s earlier communication regarding the product in February. The FDA now says that the product can remain in service for the reprocessing of endoscopes other than duodenoscopes.

CLICK HERE to see the FDA notice