ICU Medical Warning Letter Details

Summary

ICU Medical was cited for manufacturing the Medfusion® Model 4000 Syringe Infusion Pump and CADD® Solis VIP Ambulatory Infusion Pump without required premarket approval (PMA) or investigational device exemption, rendering the devices adulterated under federal law. The company also failed to submit timely 510(k) notifications to the FDA before introducing these devices into interstate commerce, resulting in misbranding violations. These compliance failures were identified during an FDA inspection of the Smiths Medical ASD facility in Minneapolis, Minnesota (acquired by ICU Medical in January 2022) conducted from July 23 through August 9, 2024.