FDA Enforcement
Class II
Ongoing
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Recall: Z-0348-2025
·
Reported November 20, 2024
Enforcement
- Recall Number
- Z-0348-2025
- Event ID
- 95505
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- November 20, 2024
- Initiation Date
- October 2, 2024
- Classification Date
- November 8, 2024
- Address
- 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States
Description
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason
The door on the Spectrum IQ Infusion pump may not be able to fully close.
Code Info
00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200
Distribution
GA, ID
Quantity
8 units