FDA: Class I recall of Ivenix Infusion System

Editor's Note

The Food and Drug Administration (FDA), on April 19, identified the recall by Fresenius Kabi USA of its Ivenix Infusion System as Class I, the most serious.

The recall was initiated because of a leak in the system that allows fluid to enter the administration set loading area near the air detector. The leak damages the electrical system, leading to loss of power and failure of the set identification sensor, which can delay or interrupt delivery of critical fluids, blood products, and medications.

The company has received 14 complaints related to this issue. No injuries or deaths have been reported.

Distribution dates were October 27, 2021, to January 30, 2023.