Recall Z-2333-2025 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
| Date | Aug 29, 2025 (initiated Aug 4, 2025) |
| Status | Open, Classified |
| Reason | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only). |
| Root cause | Software design (manufacturing process) |
| Action | Baxter issued an "URGENT MEDICAL DEVICE CORRECTION" to its consignees on 08/04/2025 via USPS first class mail. The notice described the problem, hazard involved, and actions to be Taken by customers: 1. Users should rely on their clinical judgment. When providing patient care involving high risk medications and/or critical illness, users should consider utilizing an alternate pump, if available and appropriate for the patient's treatment. 2. If an alternate pump is not available or appropriate for patient care you may continue to use the Novum IQ LVP and Novum IQ Syringe Pump consistent wit |
| Quantity | 10,101 units |
| Distribution | US distribution including Puerto Rico and OUS (International) Canada |
| 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 |