Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- November 14, 2025
- Posted
- December 16, 2025
- Recall Number
- Z-0885-2026
- Quantity
- 30 units
- Firm Location
- North Andover, MA
Reason for Recall
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Distribution
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Lot / Code Info
Software Versions 5.10.1 and prior; UDI: 00811505030122.
Root Cause
Software design
Action Taken
Consignees were emailed an "URGENT - Medical Device Field Correction" notice dated 11/14/25. The notice instructs consignees to review and become familiar with the provided notification's risk mitigation actions; the notice is to be forwarded if affected units were further distributed and users are to be notified. Consignees are to facilitate the installation of the new Ivenix Infusion Management System (version 5.2.2) and Large Volume Pump (5.10.2) software versions utilizing the provided instructions. Consignees are to note that the LVP will not be available for use during the update. Completed Customer Reply Forms may be sent via email to fkmd.fieldactions@fresenius-kabi.com. Customer questions can be directed to Customer Support via email at Ivenix_support@fresenius-kabi.com or by phone at 1-855-354-6387.