Recall Z-3065-2026

Recall number
Z-3065-2026
Event number
99557
Firm
Baxter Healthcare Corporation
Firm FEI
1417572
Product code
FRN
Status
Open, Classified
Initiated
2026-08-11
Posted
2026-08-31
Root cause
Software design
510(k) numbers
K242390, K912589, K900467, K123822, K830177, K781171, K883653, K813562, K915407, K832167, K930459, K083689, K141102, K896075, K900888, K072105, K905610, K141389, K790814, K875347, K864138, K990259, K890457, K921050, K844792, K041714, K902835, K950419, K050433, K242660

Product#

Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

Reason for Recall#

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.