Covidien Initiates Voluntary Recall of Certain Shiley Tracheostomy Tubes
MedSun: Newsletter #48, May 2010

FDA MedWatch Safety Alert

FDA and Covidien notified healthcare professionals of a recall of certain lots of its cuffed Shiley TM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product's cuff not holding air as a result of leaks in the pilot balloon inflation assembly. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death. The voluntary recall only affects lot numbers from a specific period of time.

Additional Information:

FDA MedWatch Safety Alert. Covidien Initiates Voluntary Recall of Certain Shiley Tracheostomy Tubes. April 24, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209712.htm


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