FDAHealthFebruary 4, 2026
Fresenius Kabi USA, LLC — The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
⚠️ Potential for the Cassette Loading Lever to break.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 4, 2026
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
What's affected?
- Product
- The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
- Lot code
- Model Number: LVP-0004. UDI-DI: 00811505030320
Additional details
Model Number: LVP-0004. UDI-DI: 00811505030320
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 18,444 installed bases.
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