FDAHealthNovember 3, 2025

Fresenius Kabi USA, LLC — Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

⚠️ Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: November 3, 2025

US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.

What's affected?

Product: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Brand: Fresenius Kabi USA, LLC
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: 15,862 units.

View original FDA notice →

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