PlainRecalls
FDA Devices Moderate Class II Ongoing

Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

Reported: June 18, 2025 Initiated: May 12, 2025 #Z-1964-2025

Product Description

Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

Reason for Recall

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.

Details

Units Affected
8027 units
Distribution
US Nationwide distribution.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,. Recalled by Baxter Healthcare Corporation. Units affected: 8027 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1964-2025.