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See today's BioWorld MedTech
Home » FDA warns ICU Medical for fixes for infusion pump
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FDA warns ICU Medical for fixes for infusion pump

May 13, 2025
By Mark McCarty
The U.S. FDA’s April 4, 2025, warning letter to ICU Medical Inc. cited the company for failure to file a new 510(k) for changes to software used in an infusion pump, but those changes may have been driven by problems with the pumps the company acquired when it picked up Smiths Medical in 2022. The FDA also issued a warning letter to Epicare Acquisitions LLC related to its Zenith family of laser hair removal systems.
BioWorld MedTech Regulatory U.S. FDA

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