Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administratio...
FDA Recall #Z-0885-2026 — Class I — November 14, 2025
Product Description
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Reason for Recall
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Recalling Firm
Fresenius Kabi USA, LLC — North Andover, MA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
30 units
Distribution
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Code Information
Software Versions 5.10.1 and prior; UDI: 00811505030122.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated