FDA-Device2025-06-18Class II
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Baxter Healthcare Corporation
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
8027 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1964-2025Don't want to check this manually?
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