FDA Issues Class II of Recall Silicone Close to Shaft Cuff Adjustable Neck Flange Tracheostomy Tube

The FDA is issuing a Class II recall for Arcadia Medical Corporation’s silicone close to shaft cuff adjustable neck flange tracheostomy tube. The product does not contain a punched hole above the cuff access port, as intended by the device’s design. This eliminates the user’s ability to suction secretions through this suction port, necessitating that the user revert to standard-of-care methods for suctioning secretions from around the cuffed trach tube shaft.