FDA 483 - Nexus Medical LLC - April 15, 2025

Nexus Medical, LLC in Lenexa, KS, was cited for a significant lapse in their quality system, specifically failing to revalidate a manufacturing process after changes or deviations occurred. This oversight led to the production of defective intravascular administration sets that resulted in product complaints, including devices that could not be flushed or came apart during infusion. The firm manufactured a substantial number of these affected devices before corrective actions were implemented.