Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS recallZ-1767-2025 · Baxter Healthcare Corporation · initiated Apr 24, 2025
Class I Open, Classified All recalls posted in May 2025
Is my device affected?
- 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.
- 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.
- 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
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
FDA root cause category: Device Design
What the company is doing
Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 04/24/2025 via USPS First Class Mail. The notice explained the issue, hazard, and requested the following: Actions to be Taken by Customers 1. For flow rates greater than 50 mL/hour, do not exceed a programmed standby time of 2 hours and 30 minutes. Monitor patients frequently to ensure that the appropriate infusion is being delivered. 2. Please remove the set upon powering off the device. 3. Post the enclosed informational poster with Novum IQ LVPs in your facility. 4. 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. 5. 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 (select option 2, then option 2 again) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Recall details
- Recall number
- Z-1767-2025
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Apr 24, 2025
- Posted by the FDA
- May 20, 2025
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 34,524 units
- Product code
- FRN
- FDA submissions
- K211122
- Distribution
- US and Canada
Product description
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Code information (models, lots, serial numbers)
All serial numbers
Other devices under the same FDA submission
1 device cleared under K211122 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Novum IQ 40700BAXUSBaxter Healthcare Corporation · Pump, infusion2 recalls4 deaths1,192 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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