Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library Recalled by Baxter Healthcare Corporation Due to SIGMA Spectrum Infusion Pumps with Master Drug Library,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corporation directly.
Affected Products
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Quantity: Domestic: 14,175 units; Canada: 187 units
Why Was This Recalled?
SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.
Where Was This Sold?
Natiowide, Puerto Rico and Canada
About Baxter Healthcare Corporation
Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report