WhichRecall
Class IIReported 2026-01-21

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

Recalled by Fresenius Kabi USA, LLC

Reason for Recall

Emphasizing instructions for LVP duration programming located in the IFU.

Advertisement
Recall Number
Z-1048-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-21
Reported
2026-01-21
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.
Code Info
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
Advertisement