Z-2173-2025Class I

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

Name: Z-2173-2025 Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Creator: Baxter Healthcare Corporation
Published: 2025-07-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-07-14 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS on 2025-07-14. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2173-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-07-14
Posted: 2025-08-14
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root 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.
Product codes and lots: UDI/DI 05413765851797, All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2173-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2173-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-14

Product code FRN

K211122Class IINovum IQ Large Volume PumpBaxter Healthcare Corporation / cleared 2024-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)