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Novum IQ recallZ-1964-2025 · Baxter Healthcare Corporation · initiated May 12, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1964-2025
Status
Open, Classified
Initiated by the company
May 12, 2025
Posted by the FDA
Jun 12, 2025
Recalling firm
Baxter Healthcare Corporation
Quantity
8027 units
Product code
FRN
FDA submissions
K242390
Distribution
US Nationwide distribution.

Product description

Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

Code information (models, lots, serial numbers)

UDI/DI 05413765852428, All Serial Numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K242390 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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