Class I — UrgentReported 2025-12-24

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

Recalled by Fresenius Kabi USA, LLC

Reason for Recall

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Recall Number

Z-0885-2026

Classification

Class I

Status

Ongoing

Category

device

Initiated

2025-11-14

Reported

2025-12-24

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 Info

Software Versions 5.10.1 and prior; UDI: 00811505030122.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.