Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 03, 2025 |
| Reported | December 10, 2025 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Country / region | United States MA |
Hazard
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Affected products
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Related recalls
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