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FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL MAQUET SERVO HUMIDIFIER

FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL MAQUET SERVO HUMIDIFIER

The FDA recently warned healthcare professionals of a recall of MAQUET Servo Humidifier 163 by Teleflex Medical. These devices are "placed over a surgically-created opening in the throat or a tube inserted into the trachea to warm and moisten gases breathed in by a patient." Teleflex Medical has recalled certain lots of the humidifiers distributed between June 2013 and November 2014. The reason for the recall is that cracks found in the connector and connector tubes of the humidifiers could cause leakage of oxygen and other gases, which could result in the devices not providing adequate respiratory support. This in turn could potentially cause "serious injury or death."

INMED, a manufacturing division of Teleflex Medical, has sent Urgent Field Safety Notice 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 it is likely that use of [the faulty] devices will cause serious health problems or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm435620.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm435597.htm

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