Class IIReported 2025-12-10

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Recalled by Fresenius Kabi USA, LLC

Reason for Recall

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Recall Number

Z-0848-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-03

Reported

2025-12-10

Distribution

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

Code Info

Model Number: LVP-0004. UDI-DI: 00811505030320.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.