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 | Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death. |
| Product | LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. |
| Quantity | 17 units |
| Distribution | US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI. |
| Initiated | 2024-03-07 |
| Classified | 2024-04-11 |
| Recall number | Z-1484-2024 |
| 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-1484-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94228/
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