Official recall notice

FDA DeviceClass IINotable

FDA Recall: Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL

Recall date
2026-09-09
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 00197886002300, all serial numbers

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