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FDA ISSUES RECALL NOTICE ABOUT KIMVENT* MICROCUFF* ENDOTRACHEAL TUBES

FDA ISSUES RECALL NOTICE ABOUT KIMVENT* MICROCUFF* ENDOTRACHEAL TUBES

The FDA recently warned healthcare professionals of a recall of Halyard Health's KimVent* Microcuff* Endotracheal Tubes. These devices are plastic tubes "inserted into the windpipe (trachea)... to open an airway for mechanical breathing [or]... to remove fluid that builds up in the windpipe during a procedure." Halyard Health has recalled endotracheal tubes distributed between December 2013 and October 2014. The reason for the recall is that the cuff inflation line "may detach from the tube during use", which can "reduce the amount of air that reaches the lungs." This in turn could lead to "serious health risks, including delayed patient treatment, breathing difficulties, and death."

Halyard Health has sent Urgent Voluntary Product Recall letter with safety instructions to its customers, urging them to stop using the recalled devices. The initiated recall is Class I - the most serious type of recall used when "there is a reasonable probability that use of [the faulty] products will cause serious adverse health consequences or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm428654.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm428617.htm

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