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U.S. Department of Health and Human Services

Safety

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Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula

Audience: Respiratory healthcare professionals, operating room supervisory personnel, and risk managers

FDA and Nellcor/Tyco notified healthcare professionals of a Class I recall of the Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Cannula. This recall affects 73,355 disposable units that the firm has shipped to U.S. and international customers over the last four years. The tracheostomy tube is secured in place through the tube's hub and flange assembly with the use of a holder or neck strap. The outer cannula may separate from the hub and neck flange allowing the outer cannula to travel farther into the patient's airway, leading to obstruction of the airway and subsequent lack of ventilation. Airway obstruction or failure to ventilate can lead to permanent neurological injury or death.

[August 9, 2004 - Recall Notice - FDA]