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 version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. |
| Product | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients. |
| Quantity | 30 units |
| Distribution | US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI. |
| Initiated | 2025-11-14 |
| Classified | 2025-12-16 |
| Recall number | Z-0885-2026 |
| 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-0885-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98009/
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