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FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL'S ENDOBRONCHIAL TUBES

FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL'S ENDOBRONCHIAL TUBES

The FDA recently warned healthcare professionals of a recall of Hudson RCI Endobronchial Tube by Teleflex Medical. These tubes are inserted through the mouth into the bronchi of the lungs and are "used during a medical procedure that determines how well a lung is working." In the US alone, Teleflex Medical has recalled over 62,000 of these defective medical devices that were distributed between October 2013 and May 2015. The reason for the global recall is a faulty connector that "may break or separate on the tube." This in turn could induce a device leak, "causing the patient to not receive enough oxygen... or experience respiratory distress", and may ultimately result in patient injury or death. Teleflex Medical has already received customer complaints about the endobronchial tube's connector.

The company has sent an Urgent Medical Device Recall letter with safety instructions to its customers. The initiated recall is Class I - the most serious type of recall used when "there is a reasonable probability that use of [the defective devices] will cause serious adverse health consequences or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm459827.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm459801.htm

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