FDAFDA · Food and drugs·Recall number Z-3153-2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Published October 2, 2024 · Recall initiated: August 30, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- US Nationwide.
- Lot
- UDI-DI: 00811505030122; Software Version 5.9.1 and prior
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.