ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) by Teleflex Medical: Class I Recall
MedSun: Newsletter #93, March 2014

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of the Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. The affected tracheal tube may kink during patient use. The affected products were manufactured from December 2009 through November 2013 and distributed from March 2010 through December 2013. See the firm Urgent Medical Device Recall Notification for a list of affected product codes and lot numbers. Immediately discontinue use and quarantine any products with the catalog numbers listed in the Urgent Medical Device Recall Notification.

Additional Information:

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) by Teleflex Medical – Class I Recall. FDA MedWatch Safety Alert. February 24, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387041.htm


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