Recall Z-0151-2024 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Novum IQ Syringe infusion system, Product Code 40800BAXUS
| Date | Nov 9, 2023 (initiated Oct 13, 2023) |
| Status | Open, Classified |
| Reason | Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an "Urgent Medical Device Correction" notice on 10/13/2023 via USPS first-class mail. The notice explained the issue, hazard involved, and provided mitigation procedures in accordance with the Operator's Manual until a software upgrade becomes available. For additional questions or experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867, Monday through Friday, between 7:00 am and 7:00 pm Eastern Time. |
| Quantity | 2023 units |
| Distribution | US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211125 | Novum IQ Syringe Pump Baxter Healthcare Corporation, Aug 30, 2022 |