Z-1767-2025Class I

Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS

Name: Z-1767-2025 Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Creator: Baxter Healthcare Corporation
Published: 2025-04-24
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-04-24 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS on 2025-04-24. FDA classified it as Class I and gives the reason as "There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded". 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-1767-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-04-24
Posted: 2025-05-20
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Product code: FRN Pump, Infusion
Reason for recall: There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 04/24/2025 via USPS First Class Mail. The notice explained the issue, hazard, and requested the following: Actions to be Taken by Customers 1. For flow rates greater than 50 mL/hour, do not exceed a programmed standby time of 2 hours and 30 minutes. Monitor patients frequently to ensure that the appropriate infusion is being delivered. 2. Please remove the set upon powering off the device. 3. Post the enclosed informational poster with Novum IQ LVPs in your facility. 4. Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 5. Please forward a copy of this communication to the Chief Medical Officer, Medical Director, Director of Nursing, Director of Pharmacy, Facility Risk Manager, Director of Purchasing/Central Supply, and any other departments within your institution who use the affected product. For general questions regarding this communication, or if you experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 (select option 2, then option 2 again) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Quantity in commerce: 34,524 units
Distribution: US and Canada
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1767-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1767-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-20

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)