Company: Fresenius Kabi USA, LLC
Date of Enforcement Report: 12/16/2025
Class: I
PRODUCT
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Recall Number:
Z-0885-2026
REASON:
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
RECALLING FIRM/MANUFACTURER:
Z-0885-2026
VOLUME:
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.
