Medical technologies provider Teleflex has voluntarily recalled Comfort Flo humidification system across the world.
The recalled products deliver a continuous flow of heated and humidified gas to Comfort Flo patients in professional health care environments.
The recalled products include Comfort Flo humidification system with product code 2410, Comfort Flo humidification system with remote port extension with product code 2414, corrugated Comfort Flo with product code 2415 and corrugated Comfort Flo remote temp port with product code 2416.
The recalled products have been manufactured between October 2014 and June 2019
Teleflex manufactured the recalled products between October 2014 and June 2019. The products manufactured after June 2019 are now being with the company’s new Comfort Flo columns for high flow therapy.
According to the company, the recalled product can be determined by the presence of only one white reservoir clamp on the feed tube.
The company is recalling the products as the water can flood the column and enter the circuit that may lead to the creation of an abnormal pressure differential between the water bottle and the column during high flow oxygen therapy.
Exposure of patients to water ingress may result in the aspiration of fluid into the nose and lungs, which may cause oxygen desaturation.
Teleflex said that it has secured 102 complaints of water ingress in which intervention has been needed on several patients to avoid serious injury or permanent impairment.
The recall of the Comfort Flo humidification system has been classified as a Class I recall by the US Food and Drug Administration (FDA).
The FDA describes class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Teleflex’s solutions can be used in the fields of vascular and interventional access, surgical, anaesthesia, cardiac care, urology, emergency medicine and respiratory care.
In October 2018, Teleflex acquired Essential Medical, an Exton, Pennsylvania-based medical device company that has developed the Manta vascular closure device.
