The Food and Drug Administration (FDA)
and Nellcor/Tyco have notified health care 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.
Read the MedWatch 2004 safety summary, including a link
to the FDA recall notice, at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Shiley