FDAHealthNovember 14, 2025
Fresenius Kabi USA, LLC — Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
⚠️ Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Is this relevant to me?
- Geography
- US, CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI
- Source agency
- FDA
- Category
- Health
- Published
- November 14, 2025
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
What's affected?
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Lot code
- Software Versions 5.10.1 and prior; UDI: 00811505030122.
Additional details
Software Versions 5.10.1 and prior; UDI: 00811505030122.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 30 units.
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