Class II

Medical Device Recall: Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Fresenius Kabi USA, LLC · November 21, 2025

Reason for Recall

Emphasizing instructions for LVP duration programming located in the IFU.

Distribution

US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.

States Affected

NATIONWIDE

Quantity Affected

30 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1048-2026

Status: ongoing

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