Baxter Healthcare Corporation medical device recall: Baxter Novum IQ Large Volume Pump

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.

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Jul 14, 2025. FDA classified it 31 days later, on Aug 14, 2025. Distribution reported by FDA: Worldwide distribution - US Nationwide and the country of Canada. Baxter Healthcare Corporation has 279 recalls in our records.

Recalled products (1)

• Z-2173-2025 Class I Ongoing

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

  Codes / lots: UDI/DI 05413765851797, All Serial Numbers

  Quantity: 36705 units