FDA Enforcement
Class II
Ongoing
Spectrum IQ Infusion pump, Product Code 357009
Recall: Z-1810-2024
·
Reported May 22, 2024
Enforcement
- Recall Number
- Z-1810-2024
- Event ID
- 94451
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- May 22, 2024
- Initiation Date
- April 9, 2024
- Classification Date
- May 13, 2024
- Address
- 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States
Description
Spectrum IQ Infusion pump, Product Code 357009
Reason
There is a potential for cracks on the mount of the front panel of the device.
Code Info
UDI/DI 00085412610900, Serial Numbers: 3770692, 3770755, 3770781, 3770816, 3770932, 3771122, 3771364, 3771374, 3771419
Distribution
US Nationwide distribution in the states of Ohio, Wisconsin.
Quantity
9 units