FDA Issues Early Alert for Baxter Healthcare's Infusion Pumps Over Safety Concerns
March 7, 2025
The FDA issued an early alert regarding issues with Baxter Healthcare's Spectrum infusion pumps, specifically the Sigma Spectrum Infusion System and Spectrum IQ Infusion System. The company has recommended removing certain units of these pumps from use and sale due to potential safety concerns.
The affected models include the Sigma Spectrum V6 platform and Spectrum IQ with Dose IQ Safety Software, with specific serial numbers listed for each product.
The FDA is monitoring the situation closely and will provide updates as new information becomes available. Baxter Healthcare has already notified affected customers.
Janette Wider is Editor-in-Chief for Healthcare Purchasing News.