Z-0151-2024Class I

Novum IQ Syringe infusion system, Product Code 40800BAXUS

Name: Z-0151-2024 Novum IQ Syringe infusion system, Product Code 40800BAXUS
Creator: Baxter Healthcare Corporation
Published: 2023-10-13
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-10-13 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Novum IQ Syringe infusion system, Product Code 40800BAXUS on 2023-10-13. FDA classified it as Class I and gives the reason as "Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0151-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-10-13
Posted: 2023-11-09
Recalling firm: Baxter Healthcare Corporation
Product: Novum IQ Syringe infusion system, Product Code 40800BAXUS
Product code: FRN Pump, Infusion
Reason for recall: Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.
FDA root cause: Under Investigation by firm
Action: Baxter issued an "Urgent Medical Device Correction" notice on 10/13/2023 via USPS first-class mail. The notice explained the issue, hazard involved, and provided mitigation procedures in accordance with the Operator's Manual until a software upgrade becomes available. For additional questions or experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867, Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Quantity in commerce: 2023 units
Distribution: US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0151-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0151-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09

Product code FRN

K211125Class IINovum IQ Syringe PumpBaxter Healthcare Corporation / cleared 2022-08-30

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)