Z-3065-2026 Class II Ongoing
FDA device recall Z-3065-2026 was initiated by Baxter Healthcare Corporation on August 11, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 14601 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- August 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14601 units
Product Description
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.
Distribution Pattern
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.
Code Information
UDI-DI 05413765852428, all serial numbers