Class I
Medical Device Recall: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Fresenius Kabi USA, LLC · November 14, 2025
Reason for Recall
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Distribution
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
States Affected
CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI
Quantity Affected
30 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0885-2026
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.