Z-0775-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2025
- Initiation Date
- November 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 units
Product Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Reason for Recall
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Distribution Pattern
US Nationwide distribution in the states of AL, IN.
Code Information
GTIN 00085412091570; Serial Number: 779515