Fresenius Kabi Ivenix Infusion System Connected to Second Recall in 2024

FDA has upgraded Fresenius Kabi’s voluntary recall of certain Ivenix Large Volume Pump (LVP) primary administration sets to Class I after the company identified a manufacturing defect that could cause uncontrolled medication flow.

The LVP is one of three primary components of the Ivenix infusion system, which uses air pressure to precisely control the flow of fluids to patients in hospitals and outpatient centers. The system administers fluids to patients through routes like IV, in arteries, in the spine, or under the skin and is indicated for use in adults, pediatrics, and newborns.

On August 2, Fresenius Kabi sent all affected customers an Urgent Voluntary Recall letter after identifying a manufacturing defect that would result in uncontrolled medication flow. Use of affected devices could cause medication overdose and death. The removal is limited to a specific lot: 3010538. The company has reported two injuries, and no deaths associated with the issue.

It is recommended to stop using product from lot 3010538 and to destroy or return it to the company so that replacements can be requested.  

This isn’t the first time in 2024 that Fresenius Kabi has been embroiled in a Class I recall connected to IVP. In April, MD+DI reported that FDA gave the designation to a correction initiated by the company for software anomalies. The software was updated remotely with no need to return the pumps. At the time of the Class I designation, Fresenius Kabi said that approximately 90% of customers had already implemented the software update.

“Fresenius Kabi initiated a software update in early March 2024 for its Ivenix LVPs that included both software enhancements and additional safety features to bring its pumps to the newest software status,” a spokesperson from Fresenius Kabi told MD+DI at the time. “It is important to note there have been no reports of patient harm received from Ivenix pump customers related to this software update. Fresenius Kabi informed the FDA of this need for a software update and following FDA’s review, it classified this as a recall in mid-April and published a notification on April 17, 2024.”