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U.S. Department of Health and Human Services

Medical Devices

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Shiley Tracheosoft Tracheostomy Tube and Disposable Inner Cannula

Class I Recall
Date Recall
Initiated:

July 8, 2004

 

Product:
Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula
Use:
The device is an extended length cannula (tube) with accessory components used to provide an artificial airway to assist in the treatment of a variety of respiratory diseases and airway management in adults. The tube is inserted into a tracheostomy incision in a patient’s neck and trachea. The tracheostomy tube is secured in place through the tube’s hub and flange assembly with the use of a holder or neck strap.

 

Recalling Firm:

Nellcor/Tyco Healthcare
4280 Hacienda Drive
Pleasanton, CA 94588-2719

 

Reason for Recall:

The outer cannula may separate from the hub and neck flange allowing the outer cannula to travel farther into the patient’s airway and significantly interfere with breathing and ventilation. This recall affects 73,355 disposable units that the firm has shipped to U.S. and international customers over the last four years.

 

Public Contact:

James Bonds
Senior Director, Regulatory Affairs
925-463-4371
james.bonds@tycohealthcare.com

 

FDA District:

San Francisco

 

FDA Comment:

Failure of the tracheostomy tube can allow the tube to migrate, 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. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.

 

 

For additional information on this product recall, see the Nellcor/Tyco Healthcare press release.

Also, for additional information on this product recall, see the FDA Enforcement Report.