FDA Enforcement
Class II
Ongoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Recall: Z-0776-2025
·
Reported January 8, 2025
Enforcement
- Recall Number
- Z-0776-2025
- Event ID
- 95848
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- January 8, 2025
- Initiation Date
- November 19, 2024
- Classification Date
- December 27, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States
Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Reason
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Code Info
GTIN 00085412498683; Serial Number: 2153638
Distribution
US Nationwide distribution in the states of AL, IN.
Quantity
1 unit