Z-1964-2025Class II

Baxter Novum IQ Syringe Pump, product code 40800BAXUS

Name: Z-1964-2025 Baxter Novum IQ Syringe Pump, product code 40800BAXUS
Creator: Baxter Healthcare Corporation
Published: 2025-05-12
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-05-12 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Baxter Novum IQ Syringe Pump, product code 40800BAXUS on 2025-05-12. FDA classified it as Class II and gives the reason as "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"...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1964-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-12
Posted: 2025-06-12
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Product code: FRN Pump, Infusion
Reason for recall: 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 tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 8027 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 05413765852428, All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1964-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1964-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12

Product code FRN

K242390Class IINovum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation / cleared 2024-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)