Baxter recalls Novum IQ Large Volume Pumps due to potential underinfusion when changing flow rates. This may cause incorrect medication delivery. Affected units have specific product codes and serial numbers.
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.
Baxter is recalling its Novum IQ Large Volume Pumps because changing flow rates too quickly can cause underinfusion, meaning less medication is delivered than intended. This risk is higher if the pump has been running at the current rate for a long time or the rate change is large. The recall is for specific product codes and serial numbers.
Changing flow rates too quickly can cause the pump to deliver less medication than programmed. This risk increases if the pump has been running at the current rate for a long time or the rate change is large. Improper loading of the tubing can also cause over or underinfusion.
Patients using the Novum IQ pump for medical infusions are most at risk. The recall affects specific product codes and serial numbers sold with the pump.
Check for product code REF 40700BAXUS and serial numbers listed in the recall notice. The pump's UDI/DI number is 05413765851797.
Ensure the pump door is fully open before loading the tubing and that the tubing is taut without slack in the pumping channel.
Baxter identified potential underinfusion when changing flow rates too quickly, which could lead to incorrect medication delivery. This risk increases with longer run times or larger rate changes.
Check for product code REF 40700BAXUS and serial numbers listed in the recall notice. The pump's UDI/DI number is 05413765851797.
The recall includes instructions to ensure proper loading of the tubing: the pump door must be fully open and the tubing must be taut without slack.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-2173-2025 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-2173-2025 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.