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Fresenius Kabi USA, LLC Recall: Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

Fresenius Kabi USA, LLC Recall: Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Fresenius Kabi USA, LLC; Product: Ivenix Infusion System (IIS), Large Volume Pump LVP-0004; Reason for recall: The device may experience mechanical i

Recalling firmFresenius Kabi USA, LLC
ProductIvenix Infusion System (IIS), Large Volume Pump LVP-0004
Reason for recallThe 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.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusOngoing
DistributionUS distribution to states of: CA, CO, NJ, UT, and WI.
Recall initiated20231129
Recall numberZ-0549-2024
Categorydevice
StateMA
CountryUnited States

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