Class I — Fresenius Kabi USA, LLC
| Recalling firm | Fresenius Kabi AG |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power. |
| Product | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. |
| Quantity | 32 systems |
| Distribution | US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI. |
| Initiated | 2026-05-06 |
| Classified | 2026-06-03 |
| Recall number | Z-2223-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Fresenius Kabi USA, LLC (Z-2223-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98929/
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