Fresenius Kabi recalls Ivenix Infusion System software over ‘anomalies’
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Key takeaways:
- Software related to the Ivenix Infusion System has been recalled over multiple potentially dangerous issues.
- The recall will take the form of a software update.
Large volume infusion pump software related to the Ivenix Infusion System has been recalled by its manufacturer due to multiple potentially dangerous issues, according to a press release from the FDA.
The FDA classified the recall by Fresenius Kabi USA as a class 1 recall, meaning use of the devices “may cause serious injuries or death.” No injuries or deaths associated with the software have been reported yet.
The recall covers 17 devices in the United States that were distributed between March 6, 2023, and March 20, 2024. The Ivenix Infusion System is used by hospitals and other health care facilities for administration of fluids through IVs, arterial lines and subcutaneous delivery.
“Fresenius Kabi USA, LLC is recalling their Ivenix Infusion System (IIS), LVP Software, an infusion pump software,” the FDA said in the release. “The reason for the recall is that multiple software anomalies were occurring that have the potential to result in serious patient harm or death. To remedy this issue, Fresenius Kabi is releasing a new software version (5.9.1) for the Ivenix Large Volume Pump.”
All affected customers were issued an Urgent Medical Device Field Correction on March 7. Customers are advised to call Fresenius Kabi at 978-775-8100 for help installing software version 5.9.1.
More than 1,500 Ivenix Infusion System devices came under a class 1 recall last year due to a fluid leak issue.
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