Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
FDA Recall Z-0776-2025 · Posted 2024-12-27
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Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2024-11-19
Product Quantity1 unit
Reason for Recall
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Firm Action
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]
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of AL, IN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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