FDA recall Z-0763-2025

Fresenius Kabi USA, LLC · Class I · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-12-06
Report date
2025-01-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0763-2025