The FDA has reiterated its November 2015 Safety Communication recommending that organizations using Custom Ultrasonics' Automated Endoscope Reprocessors transition to alternative methods to reprocess flexible endoscopes.
Here are five notes:
1. In November 2015, the FDA ordered Custom Ultrasonics to recall all of its Automated Endoscope Reprocessors.
2. Later that same month, Custom Ultrasonics submitted a recall strategy to the FDA. However, the FDA found it inadequate.
3. Since then, the company has made no additional proposals to the FDA to recall its AERs.
4. In January 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.
5. Thus, the FDA restated that organizations using the company's AERs transition to other reprocessing methods.