Z-1423-2025Class II

Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS

Name: Z-1423-2025 Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Creator: Baxter Healthcare Corporation
Published: 2025-03-03
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-03-03 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS on 2025-03-03. FDA classified it as Class II and gives the reason as "Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1423-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-03
Posted: 2025-03-21
Recalling firm: Baxter Healthcare Corporation
Product: Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Product code: FRN Pump, Infusion
Reason for recall: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/03/2025 via USPS first class mail. The notice explained the issue, hazard involved and requested the following: Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of Novum IQ Syringe pumps with the affected serial numbers. The product code and serial number can be found on the bottom of the syringe pump. 2. Contact Baxter to arrange for the return of the affected pumps for repair. Baxter Global Technical Services can be reached at 800-843-7867 (press option 2, then option 2) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time. 3. 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. 4. 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 Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Quantity in commerce: 149 units
Distribution: US Nationwide distribution in the states of AR, CA, FL, IA, IN, LA, MO, MT, NC, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV.
Product codes and lots: UDI/DI 05413765852428, Serial Numbers: 02A220600103, 02A221100387, 02A240800201, 02A230300471, 02A240800161, 02A220600112, 02A230100474, 02A240800343, 02A230400357, 02A240800175, 02A220700259, 02A230200471, 02A240800710, 02A230600165, 02A240800223, 02A220700176, 02A230200487, 02A240900081, 02A230600175, 02A240800513, 02A220700349, 02A230300030, 02A240900133, 02A230600176, 02A240800577, 02A220700268, 02A230300117, 02A240900265, 02A230600255, 02A240900261, 02A220700081, 02A230300125, 02A240900277, 02A230600256, 02A240900421, 02A220700140, 02A230300132, 02A240900285, 02A230600618, 02A240900742, 02A220700351, 02A230300146, 02A240900287, 02A230700137, 02A240900746, 02A220700409, 02A230300275, 02A240900282, 02A241000576, 02A240901067, 02A220700368, 02A230300287, 02A240900373, 02A220700166, 02A240901181, 02A220700428, 02A230300309, 02A240900407, 02A221000108, 02A240901422, 02A220700450, 02A230300350, 02A240900422, 02A221000346, 02A240901428, 02A220700454, 02A230300389, 02A240900423, 02A221000349, 02A240901430, 02A220700458, 02A230300477, 02A240900443, 02A221100154, 02A241000027, 02A220800010, 02A230300520, 02A240900427, 02A221100208, 02A241000051, 02A220800060, 02A230300547, 02A240900502, 02A221100201, 02A241000251, 02A220800201, 02A230400035, 02A240900681, 02A230200462, 02A241000254, 02A220800407, 02A230400145, 02A240900677, 02A230200495, 02A241000366, 02A221000109, 02A230600421, 02A240900749, 02A230300091, 02A241000479, 02A221000233, 02A230600549, 02A240900811, 02A230300342, 02A241000862, 02A221000240, 02A230600792, 02A240900981, 02A230300367, 02A241001284, 02A221000360, 02A230600820, 02A240901095, 02A230300417, 02A241001392, 02A221000099, 02A230600894, 02A240901196, 02A230300533, 02A241001413, 02A221100056, 02A230600908, 02A240901243, 02A230400030, 02A241001478, 02A221100116, 02A230700053, 02A241000498, 02A230600496, 02A241001496, 02A221100244, 02A230700043, 02A241000939, 02A240800026, 02A241100021, 02A221100260, 02A240600468, 02A241000957, 02A240800050, 02A241100037, 02A221100294, 02A240800006, 02A230300466, 02A240800069, 02A241100047, 02A221100346, 02A240800007, 02A230300467, 02A240800142.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1423-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1423-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21

Product code FRN

K242390Class IINovum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation / cleared 2024-09-05

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)