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.

Fresenius Kabi USA, LLC Medical Device Recall: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | SafeCheck