Official recall notice
FDA DeviceClass IINotable
FDA Recall: Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
- Recall date
- 2026-09-09
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Product description
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Affected products
UDI-DI 05413765852428, all serial numbers