IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | High |
| Status | ongoing |
| Recall date | November 03, 2025 |
| Reported | December 10, 2025 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Country / region | United States MA |
Hazard
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Affected products
- IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administrati
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