Fresenius Kabi Ivenix infusion system
The Ivenix infusion system. [Image courtesy of Fresenius Kabi]

The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind.

This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. since initiating the recall on Nov. 29, 2023.

The company reports no injuries or deaths related to the recall, according to the FDA.

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