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  • Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
    Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
    fda medwatch · 17d 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 · 18d ago↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
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fda recalls22
fda press21
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Infectious Disease247
Pain232
fda medwatch · 29d ago↗ source