Novum IQ Syringe infusion system, Product Code 40800BAXUS
FDA device recall Z-0151-2024 · posted 2023-11-09 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 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.
- Date initiated
- 2023-10-13
- Date posted
- 2023-11-09
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Novum IQ Syringe Pump (K211125) | Baxter Healthcare Corporation | 2022-08-30 |