Recall Z-1423-2025 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
| Date | Mar 21, 2025 (initiated Mar 3, 2025) |
| Status | Open, Classified |
| Reason | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill. |
| Root cause | Process control |
| Action | Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/03/2025 via USPS first class mail. The notice explained the issue, hazard involved and requested the following: Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of Novum IQ Syringe pumps with the affected serial numbers. The product code and serial number can be found on the bottom of the syringe pump. 2. Contact Baxter to arrange for the return of the affected pumps for repair. Baxter Global Technical Services can be reached at 800-843-7867 (press option 2, then option 2) Monday |
| Quantity | 149 units |
| Distribution | US Nationwide distribution in the states of AR, CA, FL, IA, IN, LA, MO, MT, NC, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV. |
| 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 |