openFDA Device Enforcement
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June 20, 2012–July 08, 2026
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June 01, 1997–June 30, 2026
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Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
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.