FDA Enforcement
Class II
Ongoing
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Recall: Z-2530-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2530-2024
- Event ID
- 94959
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- August 14, 2024
- Initiation Date
- June 14, 2024
- Classification Date
- August 7, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States
Description
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Reason
Improperly performed testing prior to release
Code Info
Product Code: 35700BAX2. Serial Number: 2158913.
Distribution
US Nationwide distribution in the state of Florida.
Quantity
1 unit