Class I
Medical Device Recall: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Fresenius Kabi USA, LLC · August 30, 2024
Reason for Recall
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.
Distribution
US Nationwide.
States Affected
NATIONWIDE
Quantity Affected
17 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3153-2024
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.