Device product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Z-0775-2025
Product summary
- Event
- Event 95848
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 units
- Official record key
device-enforcement:Z-0775-2025
Official wording
Reason: Devices were identified as released after repair without full testing being performed, which includes flow testing.
Code information: GTIN 00085412091570; Serial Number: 779515
Distribution pattern: US Nationwide distribution in the states of AL, IN.
Derived failure modes
-
Unknown
Devices were identified as released after repair without full testing being performed, which includes flow testing.