Teleflex (NYSE:TFX) is recalling nearly 400,000 of its Comfort Flo humidification systems because a malfunction may cause water to enter a patient’s airway. The FDA has labeled the recall Class I, its most serious designation.

The recall covers 398,320 Comfort Flo systems distributed in the U.S. between October 1, 2014 and October 31, 2019. The systems were manufactured between October 1, 2014 to June 30, 2019 and carry the model or catalog numbers 2410, 2414, 2415 or 2416.

The devices are used to provide a constant flow of heated and humidified breathing gases to neonatal, pediatric and adult patients in healthcare settings. The systems are used with the company’s Neptune heated humidifier with ConchaSmart Technology and ConchaTherm Neptune heated humidifier.

Teleflex began the recall Dec. 13, 2019 due to the risk for water to flood the column and enter the circuit in the system. Water that enters the circuit may also enter the nose and lungs of the patient. Risks to patients include low oxygen in the blood (desaturation) and the need for further treatment to prevent long-term or serious injury.

There have been 102 complaints and eight injuries with this device, including desaturation and a slower-than-normal heart rate (bradycardia). There have been no reported deaths, according to the FDA. Teleflex is asking customers to return the recalled devices. More information may be found here.