FDA Enforcement
Class I
Ongoing
Novum IQ Syringe infusion system, Product Code 40800BAXUS
Recall: Z-0151-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0151-2024
- Event ID
- 93191
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- October 13, 2023
- Classification Date
- November 9, 2023
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States
Description
Novum IQ Syringe infusion system, Product Code 40800BAXUS
Reason
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.
Code Info
All Serial Numbers
Distribution
US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.
Quantity
2023 units