Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- Recall date
- November 21, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1048-2026
- FDA classification
- Class II
- Brand / firm
- Fresenius Kabi USA, LLC
- Sold / distributed
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
Why it was recalled
Emphasizing instructions for LVP duration programming located in the IFU.
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), LVP Software: LVP-SW-0005.
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