Fresenius Kabi recalls Ivenix Infusion System software version 5.10.2 and prior due to potential LVP duration programming errors in instructions. Affected units may require software update to prevent infusion errors.
Emphasizing instructions for LVP duration programming located in the IFU.
Fresenius Kabi is recalling Ivenix Infusion System software versions 5.10.2 and older. The recall is due to possible errors in how the software handles LVP (low-volume perfusion) duration programming, which could lead to incorrect infusion rates.
The software instructions for LVP duration programming may contain errors that could lead to incorrect infusion rates. This might cause treatment to be too fast or too slow, potentially affecting patient safety. However, the hazard is not described as causing immediate injury or death.
Healthcare professionals using the Ivenix Infusion System with the affected software versions are most at risk. Patients receiving treatments through this system may be impacted if the software errors cause incorrect infusion rates.
Check if your Ivenix Infusion System has software version 5.10.2 or earlier. The product code is LVP-SW-0005, and the UDI is 00811505030122.
Verify your Ivenix Infusion System software version; affected units have version 5.10.2 or earlier.
The recall is for potential errors in LVP duration programming instructions, but the hazard is described as low risk. No immediate injury or death is mentioned.
Check if your Ivenix Infusion System has software version 5.10.2 or earlier, with product code LVP-SW-0005 and UDI 00811505030122.
The recall does not specify a remedy, so you should check for updates or contact Fresenius Kabi for guidance.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-1048-2026 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-1048-2026 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.
