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Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Recalled December 10, 2025 · FDA recall Z-0848-2026 · Fresenius Kabi USA
Hazard
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. · FDA Class II
Units
15,862 units
Sold at
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.
Description
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →