Recall Z-1767-2025 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
| Date | May 20, 2025 (initiated Apr 24, 2025) |
| Status | Open, Classified |
| Reason | 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 | Device Design |
| Action | 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 notificat |
| Quantity | 34,524 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211122 | Novum IQ Large Volume Pump Baxter Healthcare Corporation, Mar 29, 2024 |