Z-2333-2025Class I

Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump

Name: Z-2333-2025 Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Creator: Baxter Healthcare Corporation
Published: 2025-08-04
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-08-04 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump on 2025-08-04. FDA classified it as Class I and gives the reason as "Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2333-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-08-04
Posted: 2025-08-29
Recalling firm: Baxter Healthcare Corporation
Product: Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Product code: FRN Pump, Infusion
Reason for recall: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Baxter issued an "URGENT MEDICAL DEVICE CORRECTION" to its consignees on 08/04/2025 via USPS first class mail. The notice described the problem, hazard involved, and actions to be Taken by customers: 1. Users should rely on their clinical judgment. When providing patient care involving high risk medications and/or critical illness, users should consider utilizing an alternate pump, if available and appropriate for the patient's treatment. 2. If an alternate pump is not available or appropriate for patient care you may continue to use the Novum IQ LVP and Novum IQ Syringe Pump consistent with the following actions: - If a blank Run screen is displayed during an infusion on the Novum IQ LVP, the user should open the door, press the tubing into load point 3, then load point 4, to turn the light green, and close the door. If a blank Run screen is displayed during an infusion on the Novum IQ Syringe Pump, the user should unload, then reload the syringe. If these actions do not resolve the blank screen, both LVP and Syringe Pump users should power-cycle the pump, select "Yes" to the new patient prompt, and reprogram the infusion. - To prevent a false motor movement system error, do not program the Novum IQ syringe pump to infuse below the Minimum Recommended Flow Rate for a syringe size of 10 mL or greater. 3. Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. 4. Please forward a copy of this communication to any departments within your institution who use the affected product. 5. Print and post Attachment A in areas frequented by potential users. 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 (select option 2, then option 2 again) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Quantity in commerce: 10,101 units
Distribution: US distribution including Puerto Rico and OUS (International) Canada
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-2333-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2332-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2333-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29
Z-2334-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-08-29

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)