ICU Medical, Inc. – FDA Warning Letter, Aug 9, 2024

On April 4, 2025, the FDA issued a Warning Letter to ICU Medical, the acquirer of Smiths Medical ASD, following an inspection from July 23 to August 9, 2024, at their Minneapolis, Minnesota facility. The inspection revealed that the Medfusion® Model 4000 Syringe Infusion Pump and CADD® Solis VIP Ambulatory Infusion Pump are adulterated and misbranded.

The devices are adulterated under section 501(f)(1)(B) of the Act because ICU Medical lacks an approved premarket approval (PMA) application or an investigational device exemption. They are also misbranded under section 502(o) for failing to timely notify the FDA of their intent to introduce these devices into interstate commerce, as required by section 510(k).

While previous versions of these devices had 510(k) clearances (K111386 for Medfusion® Model 4000 in 2011 and K111275 for CADD® Solis VIP in 2013), ICU Medical failed to submit new premarket notifications for significant changes or modifications that could affect device safety or effectiveness, as required by 21 CFR 807.81(a)(3)(i). These changes included software updates to address issues identified via adverse event reports and modifications to