Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Recall date
- December 6, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0763-2025
- FDA classification
- Class I
- Brand / firm
- Fresenius Kabi USA, LLC
- Sold / distributed
- US distribution to states of: ID, MN, NV, TX, VA, WI.
Why it was recalled
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
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