Fresenius Kabi recalls Ivenix Infusion System software version 5.9.2 and earlier due to potential pump failure during alarms or infusion switching. Affected units sold in hospitals and outpatient care.
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
Fresenius Kabi is recalling Ivenix Infusion Systems with software version 5.9.2 or earlier because the pump could stop working during repeated alarms or switch infusions incorrectly. This could lead to improper fluid delivery in medical treatments.
The software may stop functioning if an alarm condition is paused 70 times or more. It can also switch to a primary infusion when a secondary infusion starts exactly at the end of a primary one, causing the primary to continue at its original rate.
Healthcare providers using the Ivenix Infusion System in hospitals or outpatient care settings are most at risk. Patients receiving infusions with this software version may experience incorrect fluid delivery.
Check for the Ivenix Infusion System with software version 5.9.2 or earlier. The product is indicated for hospital and outpatient care use, and was sold with the UDI-DI: 00811505030122.
Contact Fresenius Kabi to get the latest software version for the Ivenix Infusion System.
No, the Ivenix Infusion System is intended for hospital and outpatient care environments only.
Check the software version on your Ivenix Infusion System; versions 5.9.2 and earlier are affected.
Contact Fresenius Kabi to update to the latest software version to prevent potential pump failure.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-1019-2025 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-1019-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
