Teleflex Recalls Tracheal Tube for Kinking During Use

February 24, 2014 — Teleflex Medical Inc. has recalled a tracheal tube following complaints that it can kink during use.The recalled tracheal tube is inserted into a patient’s windpipe (trachea) through the nose or mouth and used to maintain an open airway.

A kink in the tube could deprive a patient of adequate ventilation, which could lead to oxygen deprivation and death. The U.S. Food and Drug Administration (FDA) has classified the action as a Class 1 recall, which means there is a reasonable probability that the defect could cause severe injury or death.

Teleflex recalled the ISIS HVT Tracheal Tube Cuffed with subglottic secretion suction port (with or without Preloaded Stylet). It has a suction port and a separate line for subglottic secretion suctioning. The device is designed to provide airway access and ventilation on a short-term or long-term basis.

The affected products were manufactured from March 2010 through December 2013. The recall was initiated on January 6 when Teleflex sent their customers an Urgent Medical Device Recall Notification.

FDA Recommendation:

“Immediately discontinue use and quarantine any products with the catalog numbers listed in the Urgent Medical Device Recall Notification. Complete the Recall Acknowledgement Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions about this recall, customers can call Teleflex Medical at 1-866-804-9881, 8 am to 8 pm, Eastern Time, Monday through Friday.”

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