Teleflex Medical is recalling some of its tracheal tubes because of a defect that may cause the tube to kink, which can deprive patients from receiving adequate oxygen or completely cut off the oxygen supply, which can lead to serious injuries including death. Tracheal tubes are devices inserted into a patient’s windpipe, or trachea, through the nose or mouth and used to maintain an open airway.
The recall involves the Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. The products were manufactured from December 2009 through November 2013 and distributed from March 2010 through December 2013.
In January, Teleflex Medical sent its customers an Urgent Medical Device Recall Notification urging them to immediately discontinue use and quarantine any products affected by the recall. The company is providing its customers with information on how to return the devices.
This recall is classified as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and patients are encouraged to report any adverse events associated with these devices to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.