medical Class I Updated 2024-10-02

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Sof

Recalled Product

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00811505030122; Software Version 5.9.1 and prior
View official government recall

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