Fresenius Kabi recalls Ivenix Infusion System software versions 5.10.1 and earlier due to potential patient harm or death risks. Affected units may require software update or replacement.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Fresenius Kabi is recalling certain versions of their Ivenix Infusion System software that could cause serious patient harm or death. Patients using these software versions should contact the company for updates or replacements.
Software versions 5.10.1 and earlier have anomalies that could lead to serious patient harm or death during fluid administration. These issues may cause improper fluid delivery or system malfunctions.
Patients using the Ivenix Infusion System with software versions 5.10.1 and earlier are affected. Healthcare providers administering fluids to patients with this software are at highest risk.
Check if your Ivenix Infusion System software version is 5.10.1 or earlier. The unique device identifier (UDI) for affected units is 00811505030122.
Immediately stop using the Ivenix Infusion System software version 5.10.1 and earlier as it poses a risk of serious patient harm or death.
Software versions 5.10.1 and earlier are affected.
Check if your Ivenix Infusion System software version is 5.10.1 or earlier. The unique device identifier (UDI) for affected units is 00811505030122.
Contact Fresenius Kabi immediately to stop using the software and get instructions for a safe alternative.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-0885-2026 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-0885-2026 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.
