Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Recall
- Recall Number
- Z-0775-2025
- Event Number
- 95848
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 19, 2024
- Posted
- December 27, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Devices were identified as released after repair without full testing being performed, which includes flow testing.
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 [email protected]
US Nationwide distribution in the states of AL, IN.
1 units