Novum IQ recallZ-2173-2025 · Baxter Healthcare Corporation · initiated Jul 14, 2025

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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 change of greater than 100%. 2. If the delay associated with changing the pump and/or infusion set would prove unacceptable, prior to initiating a bolus infusion or a rate change of greater than 100%, users should move the administration set downstream (towards the patient) approximately 0.5 inches by following steps A through C below. A. Please follow the instructions for unloading the set in section 4.4, Unloading an Administration Set, of the Novum IQ LVP Operator s Manual (refer to enclosed Attachment A). - To prevent free flow, ensure downstream roller clamp is fully closed. B. Once unloaded, move the administration set downstream by moving the slide clamp toward the container by 0.5 inches. C. After moving the slide clamp, reload the administration set. Please follow the instructions for loading the set in section 4.3, Loading an Administration Set, of the Novum IQ LVP Operator s Manual (refer to enclosed Attachment A). - Once the tubing has been loaded, the door closed and the slide clamp has been ejected, ensure that the downstream roller clamp is fully open. D. Initiate replacement of the administration set at the first safe opportunity to do so, or check regularly to ensure the infusion proceeds at the expected rate. 3. To prevent misloading, please follow the instructions for loading the set in section 4.3, Loading an Administration Set, of the Novum

Recall details

Recall number

Z-2173-2025

Status

Open, Classified

Initiated by the company

Jul 14, 2025

Posted by the FDA

Aug 14, 2025

Recalling firm

Baxter Healthcare Corporation

Quantity

36705 units

Product code

FRN

FDA submissions

K211122

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Novum IQ 40700BAXUS

  Baxter Healthcare Corporation · Pump, infusion
  2 recalls4 deaths1,192 reports

Product lines

• Novum IQBaxter Healthcare Corporation · 3 models · 1,540 reports · 7 recalls