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- Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing DevicesVolara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.fda medwatch · 16d ago↗ source
- Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.fda medwatch · 17d ago↗ source
- FDA Proposes Rule to Modernize Drug Manufacturing RegistrationThe U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a…