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 | Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. |
| Product | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. |
| Quantity | 15,862 units |
| Distribution | US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI. |
| Initiated | 2025-11-03 |
| Classified | 2025-12-01 |
| Recall number | Z-0848-2026 |
| 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-0848-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97939/
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