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FDA ISSUES RECALL NOTICE ABOUT PEDIATRIC ANESTHESIA BREATHING DEVICE

FDA ISSUES RECALL NOTICE ABOUT PEDIATRIC ANESTHESIA BREATHING DEVICE

The FDA recently warned healthcare professionals of a recall of Teleflex Medical's Hudson RCI Pediatric Anesthesia Breathing Circuits. These medical devices are used to administer medical gases to pediatric patients during anesthesia. Teleflex Medical has recalled breathing circuits with certain lot numbers distributed between June 2013 and May 2014. The reason for the recall is a defect that could cause the devices to "crack or break before or during use." This in turn could lead to serious health issues, "including delayed patient treatment, breathing difficulties, or death if not replaced immediately."

Teleflex Medical has sent 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 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/ucm417868.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm417731.htm

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