Baxter SIGMA Spectrum Pump (Baxter) – Incomplete Testing (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
GTIN 00085412091570, Serial Number: 779515
Products Sold
GTIN 00085412091570; Serial Number: 779515
Baxter Healthcare Corporation is recalling Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX due to Devices were identified as released after repair without full testing being performed, which includes flow testing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026