The Class I FDA recall comes after an earlier voluntary recall of the devices in January by Teleflex. The announcement included the a list of affected product codes and lot numbers.
According to an FDA announcement, the affected tracheal tube may kink during patient use. Affected products were manufactured from December 2009 through November 2013 and distributed from March 2010 through December 2013.
If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death, according to the FDA.
The FDA recommended: “Immediately discontinue use and quarantine any products with the catalog numbers listed in the Urgent Medical Device Recall Notification.”