Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA Recall #Z-0848-2026 — Class II — November 3, 2025
Product Description
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Reason for Recall
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Recalling Firm
Fresenius Kabi USA, LLC — North Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15,862 units
Distribution
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.
Code Information
Model Number: LVP-0004. UDI-DI: 00811505030320.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated