Class II — 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 II |
| Status | Ongoing |
| Reason | Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation. |
| Product | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. |
| Quantity | 6 units |
| Distribution | US Nationwide distribution in the state of Minnesota. |
| Initiated | 2025-09-03 |
| Classified | 2025-10-28 |
| Recall number | Z-0378-2026 |
| 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 II recall — Fresenius Kabi USA, LLC (Z-0378-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97554/
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