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.
The safety of your products should always be your top priority. Many, however, experience unanticipated problems and end up recalling drugs or devices. Drug and Device Recalls Boot Camp will take you through the ins and outs of handling recalls, so put your name on the list today.