Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
This recall is currently active, issued December 27, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- November 19, 2024
- Posted
- December 27, 2024
- Recall Number
- Z-0776-2025
- Quantity
- 1 unit
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Distribution
US Nationwide distribution in the states of AL, IN.
Lot / Code Info
GTIN 00085412498683; Serial Number: 2153638
Root Cause
Process control
Action Taken
Customers were contacted via telephone beginning 11/19/24. Baxter Healthcare is calling to notify you of a potential issue with the Spectrum infusion pump. One of your devices has been identified as released after repair without full testing being performed, which includes flow testing. Baxter is requesting the return of the impacted infusion pump to perform all tests required and confirm that the infusion pump performs as expected. As part of this process, we need to make you aware of the potential hazard associated with flow related issues. Flow issues may cause excessive therapy, free-flow condition, insufficient therapy or interruption of therapy. These may lead to serious adverse health consequences, including permanent injury and death. Send signed form to Global CORP Service Quality Field Actions Global_CORP_Service_Quality_Field_Actions@baxter.com