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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Baxter Healthcare Corporation 2025-08-20 Health critical FDA
Health · FDA · Recall #FDA-Z-2173-2025

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

Issued August 20, 2025 · Baxter Healthcare Corporation

In August 2025, Baxter Healthcare Corporation recalled the Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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 you should do

  1. 1 Stop using Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Baxter Healthcare Corporation to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Baxter Healthcare Corporation
Category
Health
Recall date
August 20, 2025
Units affected
Not reported
Sold at
Worldwide distribution - US Nationwide and the country of Canada.
Recall number
FDA-Z-2173-2025
Made in
United States
Issuing agency
FDA

In context

  • Baxter Healthcare Corporation has 36 recalls in our database, including 5 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 691st Health recall we've logged in 2025.
Read the official FDA notice

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