Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays - Recall
MedSun: Newsletter #51, August 2010

FDA MedWatch Safety Alert

Affected 6PERC or 8PERC Shiley Tracheostomy Tube cuffs may not be able to hold air due to a leak in the pilot balloon inflation assembly. If a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal.

Additional Information:

FDA MedWatch Safety Alert. Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays. July 22, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220022.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun