FDA Enforcement
Class I
Ongoing
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Recall: Z-1767-2025
·
Reported May 28, 2025
Enforcement
- Recall Number
- Z-1767-2025
- Event ID
- 96721
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 28, 2025
- Initiation Date
- April 24, 2025
- Classification Date
- May 20, 2025
- Address
- 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States
Description
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Reason
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
Code Info
All serial numbers
Distribution
US and Canada
Quantity
34,524 units