Device recall
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
- Recall number
- Z-3065-2026
- Event id
- 99557
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Report date
- Sep 9, 2026
- Posted
- Aug 31, 2026
- Initiated
- Aug 11, 2026
- Center classification date
- Aug 31, 2026
- Product code
- FRN
- Device type
- Pump, Infusion
- Reason
- A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
- Root cause
- Software design
- Quantity
- 14601 units
- Code info
- UDI-DI 05413765852428, all serial numbers
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K242390
- Location
- Deerfield, IL, United States