Recall Z-2173-2025— Baxter Healthcare Corporation

Name: FDA recall Z-2173-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-14

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-07-14. It names one FDA 510(k) clearance: K211122. Product: Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS. 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 experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Ongoing
Initiated: 2025-07-14
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K211122 — Novum IQ Large Volume PumpBaxter Healthcare Corporation·cleared 2024-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

Reason for recall

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 experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

Data sourced from openFDA. This site is unofficial and independent of the FDA.