FDA: Class I recall of AirLife Humidification Chamber, Heated Breathing Circuit Kits

Editor's Note

The Food and Drug Administration (FDA) on January 31 classified the recall by Vyaire Medical (Mettawa, Illinois) of its AirLife Humidification Chamber and Heated Breathing Circuit Kits as Class I, the most serious.

The recall was initiated because of a manufacturing error that may cause parts of the chamber to split apart into layers, allowing water to overflow the chamber and back up into the breathing circuit. If this occurs, an excessive amount of water could enter a patient's airway or lungs and lead to serious adverse consequences, including injury or death.

Manufacturing dates for the recalled lots were May 18 to September 28, 2017, and the distribution dates were July 3 to November 10, 2017.

Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death.

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