The FDA has removed two dialysis-related product codes from its device shortage list.
The products — kidney perfusion system (product code KDN) and disposable kidney perfusion set (product code KDL) — had been on the FDA’s shortage list since January 2022.
The agency attributed the shortages to a “shortage or discontinuance of a component, part or accessory of the device” and shipping delays.
As of the May 2023 expiration of the COVID-19 public health emergency, the FDA no longer requires medical device manufacturers to report product shortages, though the agency encourages voluntary reporting of device production interruptions or permanent discontinuations.
The medical device shortages list now only includes five product codes, including automated external defibrillators (AEDs) and two types of oxygenator devices intended for extracorporeal circulation:
BYS: Oxygenators for long-term support (greater than 6 hours), added to…