—#213458

Product

Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K211122
Affected lot / code info: All serial numbers

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US and Canada

Timeline

Recall initiated: 2025-04-24
Posted by FDA: 2025-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213458. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.