FDAFDA · Food and drugs·Recall number Z-2223-2026
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Published June 10, 2026 · Recall initiated: May 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Lot
- Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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