Class II

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

Fresenius Kabi USA, LLC · November 3, 2025

Reason for Recall

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Distribution

US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.

States Affected

NATIONWIDE

Quantity Affected

15,862 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0848-2026

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.