Sunmed Holdings LLC (also trading as Ventlab LLC) is updating its IFU for the manual resuscitators to include a warning statement. A safety bulletin was issued relative to the use of accessories (e.g., peep valve) on the exhalation port of the manual resuscitator which may increase the backward leak due to increased expiratory resistance and that monitoring of end tidal carbon dioxide is recommended in critically ill patients. Recall start date: October 11, 2023
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