Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
FDA Recall #Z-1048-2026 — Class II — November 21, 2025
Product Description
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Reason for Recall
Emphasizing instructions for LVP duration programming located in the IFU.
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
30 units
Distribution
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.
Code Information
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated