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Recall Observatory FDA recall evidence

Device product

Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

Z-1964-2025

May 12, 2025

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 96822
Status
Ongoing
Classification
Class II
Quantity
8027 units
Official record key
device-enforcement:Z-1964-2025

Official wording

Reason: Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.

Code information: UDI/DI 05413765852428, All Serial Numbers

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    design issue