Recall Z-1964-2025— Baxter Healthcare Corporation

Name: FDA recall Z-1964-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-12

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-05-12. It names one FDA 510(k) clearance: K242390. Product: Baxter Novum IQ Syringe Pump, product code 40800BAXUS,. 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-05-12
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K242390 — Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation·cleared 2024-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.