On February 24, the Food and Drug Administration (FDA) announced the recall of Teleflex Medical’s ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with or without Preloaded Stylet). The tube may kink and cause serious injury or death for the patient.
This recall is a Class I FDA recall, the most serious category, reserved for situations in which there is a reasonable probability that the use of or exposure to the product “will cause serious adverse health consequences or death.”
The affected tracheal tubes were manufactured from December 2009 through November 2013 and distributed from March 2010 through December 2013. A complete list of the recalled products, with their lot numbers, is contained in the Urgent Medical Device Recall Notification.
A tracheal tube is a device inserted into a patient’s trachea (windpipe) through the nose or mouth to maintain an open airway, the FDA explains. If the tube kinks, it can deprive the patient of oxygen, partially or completely, causing serious injury or death.
According to the recall announcement, healthcare professionals should immediately discontinue use of the recalled tracheal tubes and quarantine the products until they can be returned to the manufacturer. Customers are asked to complete and submit a Recall Acknowledgement Form (which can be downloaded or obtained by calling 1-800-332-1088). Fax the form to Teleflex at 1.866.804.9881, Attn: Customer Service. For questions about this recall, customers can call Teleflex Medical at 1.866.804.9881, 8 a.m. to 8 p.m., Eastern Time, Monday through Friday.
To report adverse events involving the product, physicians and patients should use the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.htm.