Class I Recall Issued for Teleflex Endobronchial Tube
On June 1, 2015, Teleflex Medical notified consumers of an Urgent Medical Device Recall relating to its endobronchial tube, as well as corresponding parts and accessories. According to the recall notification, tubes and parts manufactured and distributed between October 2013 and May 2015 may be defective. The recall comes after the company received consumer complaints alleging that the double swivel connector on Teleflex’s endobronchial tubes was separating from the device or breaking.
An endobronchial tube is a device that is inserted through a patient’s main airway into the lungs, and helps to determine the degree to which a patient’s lungs are functioning. When the connector on the tube separates or breaks, the endobronchial tube has the potential to leak—causing the patient to experience respiratory distress and hypoxia. Such conditions can lead to severe injury and death.
The Telefax Medical Device Recall Notification urges consumers to discontinue the use of any product that may have been affected by the defect. The recall has been classified by the FDA as Class I—a classification in which the Administration believes that there is a reasonable probability of a device causing severe adverse health effects or death.
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