Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Recall date
- September 3, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0378-2026
- FDA classification
- Class II
- Brand / firm
- Fresenius Kabi USA, LLC
- Sold / distributed
- US Nationwide distribution in the state of Minnesota.
Why it was recalled
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
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