The QMN Weekly Bulletin
Quality / Medical Devices / Regulatory Affairs

FDA Issues Safety Alert on Trach Tube

March 7, 2014

The FDA is asking healthcare providers to report adverse events related to Teleflex Medical’s ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. The device — subject to an ongoing Class I recall — may kink during use, potentially depriving patients of adequate ventilation and causing serious injury or death. Providers are also advised to stop using and quarantine any affected tracheal tubes, which were manufactured between December 2009 and November 2013 and distributed from March 2010 through December 2013. Teleflex initiated the recall on Jan. 6.

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