The FDA is revising its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics regarding its November 2015 Recall Order.
- On Nov. 12, 2015, in accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics (Consent Decree), FDA ordered Custom Ultrasonics to recall, at its expense, all of its Automated Endoscope Reprocessors (AERs).
- On Nov. 24, 2015, Custom Ultrasonics submitted a recall strategy to the FDA, which the Agency found inadequate. Custom Ultrasonics has to date made no additional proposals to FDA to recall its AERs.
- On Jan. 29, 2016, the FDA sent a letter to Custom Ultrasonics reinforcing the terms of the Recall Order and requiring Custom Ultrasonics to remove its AERs from the market. The FDA further notified Custom Ultrasonics that it could take additional measures under the Consent Decree should Custom Ultrasonics fail to initiate or diligently implement the recall or take other required actions.
- Because Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the Agency continues to recommend on Feb. 23, 2016, that healthcare facilities using Custom Ultrasonics AERs transition to alternative methods to reprocess flexible endoscopes as soon as possible, as emphasized in its Nov. 13, 2015 Safety Communication.