Covidien Shiley Adult Tracheostomy Tubes: Class I Recall - Reports Of Volume Leakage And/or Disconnection Between The Inner And Outer Cannulae
MedSun: Newsletter #76, September 2012

FDA Medical Device Safety

FDA notified healthcare professionals that Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to reports of volume leakage and/or disconnection between the inner and outer cannulae, which were observed during mechanical ventilation of patients. Certain lots of Shiley size 8 adult, reusable, cuffed tracheostomy tubes are included in this product recall.

Additional Information:

FDA Medical Device Safety. Covidien Shiley Adult Tracheostomy Tubes: Class I Recall - Reports Of Volume Leakage And/or Disconnection Between The Inner And Outer Cannulae. August 15, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm315634.htm


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