FDAHealthNovember 21, 2025
Fresenius Kabi USA, LLC — Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
⚠️ Emphasizing instructions for LVP duration programming located in the IFU.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 21, 2025
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
What's affected?
- Product
- Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- Lot code
- Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Additional details
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 30 units.
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