FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
- Recall number
- Z-2334-2025
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
- Status
- Open, Classified
- Initiated
- 2025-08-04
- Posted
- 2025-08-29
- Terminated
- not on file
- Reason
- 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
- 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
- 22703 units
- Distribution
- US distribution including Puerto Rico and OUS (International) Canada
- Lot, serial or model codes
- UDI/DI N/A, All Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28