—#213729

Product

Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K242390
Affected lot / code info: UDI/DI 05413765852428, All Serial Numbers

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 the repair of your Novum IQ syringe pumps. Please note you will be receiving this repair from Baxter at no charge. 3. Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. Please forward a copy of this communication to the Chief Medical Officer, Medical Director, Director of Nursing, Director of Pharmacy, Facility Risk Manager, Director of Purchasing/Central Supply, and any other departments within your institution who use the affected product. For general questions regarding this communication, or if you 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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-05-12
Posted by FDA: 2025-06-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.