Recall Z-3066-2026— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2026-08-11. It names one FDA 510(k) clearance: K242390. Product: Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL. 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..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-11
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.