Hazard description
Tracoe is issuing a Field Safety Notice as the application bears a very low risk that the silicone sleeve may detach from the guiding catheter when removing the insertion system of the tracheostomy tube. The sleeve may remain in the cannula and block it, requiring an immediate cannula change, or it may slip into the trachea, necessitating immediate bronchoscopy removal. The incidence rate is very low.
RecallTracker