SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 28, 2025 |
| Reported | January 28, 2026 |
| Recalling firm | Baxter Healthcare Corporation |
| Country / region | United States IL |
Hazard
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
Affected products
- SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
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