Class II

Medical Device Recall: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Fresenius Kabi USA, LLC · September 3, 2025

Reason for Recall

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

Distribution

US Nationwide distribution in the state of Minnesota.

States Affected

NATIONWIDE

Quantity Affected

6 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0378-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.