Teleflex, a medical device company focused on critical care and surgery, has issued a worldwide voluntary recall of COMFORT FLO Humidification system
The system allows a continuous flow of heated and humidified gas to patients in a healthcare environment.
Recalled COMFORT FLO products include COMFORT FLO Humidification System with product code 2410, COMFORT FLO Humidification System with Remote Port Extension with 2414 product code, Corrugated COMFORT FLO with product code of 2415 and COMFORT FLO Remote Temp Port with product code of 2416.
These products were manufactured between October 2014 and June 2019.
The products manufactured after June last year are being packaged with new system’s columns for high flow therapy.
The recalled products have only one white reservoir clamp on the feed tube, differentiating itself from the new product, which has two blue reservoir clamps on the feed tube.
According to the company, these product codes are being recalled due to the potential for water to flood the column, entering the circuit when an abnormal pressure differential gets created between water bottle and column during high flow oxygen therapy.
The result of exposure to water ingress is the aspiration of fluid into the nose and lungs, which may lead to oxygen desaturation.
The company stated it received 102 complaints of water ingress and intervention was needed on several patients to prevent severe injury or even permanent impairment.
Teleflex has not received any reports of death.
The US Food and Drug Administration (FDA) categorised this recall as Class I.
Teleflex has alerted consumers to discontinue use and return all affected products to the company.