Class I

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

Fresenius Kabi USA, LLC · December 6, 2024

Reason for Recall

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

Distribution

US distribution to states of: ID, MN, NV, TX, VA, WI.

States Affected

ID, MN, NV, TX, VA, WI

Quantity Affected

1,520 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0763-2025

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.