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On October 7, 2014, Teleflex Medical recalled their Hudson RCI pediatric breathing circuits because the ends of the devices may crack or break before or during use. This could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.
Anesthesia circuits deliver a mixture of anesthesia and/or other gases from a mechanical
ventilator to the patient. These devices are used in hospitals to care for pediatric patients. The devices were manufactured between March 2013 and July 2014.
On September 8, 2014, Teleflex Medical sent an urgent medical device recall to all affected customers advising them to immediately discontinue use of the affected products and quarantine or return them.
This recall has been categorized as a Class I recall. The F.D.A. indicates that Class I recalls are the most serious type of recall, involving products that can cause serious injury or death.
Click below for additional information:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm417731.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
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