Class 1 Device Recall Baxter Novum IQ

• Date Initiated by Firm: July 14, 2025
• Date Posted: August 14, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2173-2025
• Recall Event ID: 97164
• 510(K)Number: K211122
• Product Classification: Pump, infusion - Product Code FRN
• Product: Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
• Code Information: UDI/DI 05413765851797, All Serial Numbers
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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
• Quantity in Commerce: 36705 units
• Distribution: Worldwide distribution - US Nationwide and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN