Recall Z-1964-2025 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
| Date | Jun 12, 2025 (initiated May 12, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Baxter issued an URGENT MEDICAL DEVICE RECALL notice to is consignees on 05/12/2025 via USPS First Class Mail. The notice explained the issue, risk, and requested the following: Actions to be Taken by Customers 1. Customers may continue to use the Novum IQ syringe pump until the pumps can be repaired. If the pump detects a syringe when no syringe is present, or you experience System Error 21502 (Flange Sensor Failure), power cycle the device and reload the syringe. Complete the therapy and remove the pump from service. 2. A Baxter representative will contact your facility to coordinate |
| Quantity | 8027 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242390 | Novum IQ Syringe Pump (40800BAXUS) Baxter Healthcare Corporation, Sep 5, 2024 |