| Abstrakt: |
Smiths Medical has issued an Urgent Medical Device Notification to inform customers of a potential issue with certain Bivona Tracheostomy Tubes. The notification states that if the flange on the tube is torn or broken, it may not stay in position in the trachea, which can lead to tracheostomy displacement or decannulation. This could result in an inability to properly ventilate or protect the airway and may contribute to a catastrophic adverse event. Customers and distributors have been sent a letter outlining the risk and providing steps to determine if their devices are affected. For more information, customers can contact Smiths Medical. [Extracted from the article] |
