Z-0776-2025 Class II Ongoing
FDA device recall Z-0776-2025 was initiated by Baxter Healthcare Corporation on November 19, 2024 and is designated Class II. Reason for recall: Devices were identified as released after repair without full testing being performed, which includes flow testing. The recall status is ongoing. Affected quantity: 1 unit.
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 unit
Product Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
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 00085412498683; Serial Number: 2153638