Fresenius Kabi recalls Ivenix Infusion System software versions 5.0.0 and 5.0.1 due to potential flow rate timing issues that could exceed 6 minutes in certain conditions. Affected units have specific software and part numbers.
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
Fresenius Kabi is recalling software versions 5.0.0 and 5.0.1 for their Ivenix Infusion System pumps. This software version may cause flow rates between 50-200 ml/hr to take longer than 6 minutes to start, which could lead to complications if air bubbles get trapped in the pump.
The software may cause flow rates between 50 and 200 ml/hr to take longer than 6 minutes to start. This happens when air bubbles get trapped in the pump's intermediate chamber, potentially causing delays in fluid delivery.
Healthcare providers using the Ivenix Infusion System in hospitals or outpatient settings with the specific software versions 5.0.0 or 5.0.1 are affected. Patients receiving infusions through this system may be at risk if air bubbles get trapped in the pump.
Check for software versions 5.0.0 or 5.0.1 labeled as LVP-SW-0004 on the Ivenix Infusion System (IIS) Large Volume Pump. These versions are used in hospitals and outpatient care settings for fluid administration.
Look for software version numbers 5.0.0 or 5.0.1 on the Ivenix Infusion System pump.
Software versions 5.0.0 and 5.0.1 (part number LVP-SW-0004) are affected.
The software may cause flow rates between 50-200 ml/hr to take longer than 6 minutes to start, which could lead to complications if air bubbles get trapped in the pump.
No, the recall does not require immediate discontinuation. Users should check the software version and consider updating if needed.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-2635-2023 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-2635-2023 from Fresenius Kabi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
