—#212754

Product

Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K242390
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-03-03
Posted by FDA: 2025-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212754. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.