Recall Z-2173-2025 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
| Date | Aug 14, 2025 (initiated Jul 14, 2025) |
| Status | Open, Classified |
| Reason | Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experience |
| Root cause | Device Design |
| Action | Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/14/2025 via USPS First Class Mail. The notice explained the potential for under-infusion due to 1) when transitioning from a lower to higher flow rate, and/or 2) set misloading; hazard involved and requested the following: Actions to be Taken by Customers 1. Users should rely on their clinical judgment. When the delay associated with changing the pump and infusion set would NOT prove detrimental to the patient, users should change out the pump and infusion set prior to initiating a bolus infusion or a rate cha |
| Quantity | 36705 units |
| Distribution | Worldwide distribution - US Nationwide and the country of 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 |