Manufacturer has received reports of events related to airway obstruction while using the impacted device. Not following the instructions for use (IFU) and over-inflating the cuff increases intra-cuff pressure, which can cause the silicone cuff to extend, herniate, or distort over the end of the tube and/or the murphy-eye causing obstruction of the patient's airway and loss of ventilation. Manufacturer is notifying customers to carefully review and adhere to the instructions for use (IFU). Manufacturer is also providing additional recommendations on steps to follow when encountering obstruction. Recall start date: Apr 29, 2022
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