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Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Recalled December 27, 2023 · FDA recall Z-0549-2024 · Fresenius Kabi USA
Hazard
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death. · FDA Class I
Units
938 US
Sold at
US distribution to states of: CA, CO, NJ, UT, and WI.
Description
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
Product
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →