The manufacturing error could cause the chamber to split and allow water into the patient’s breathing circuit.
The Food and Drug Administration (FDA) today released a Class I recall notice for select Vyaire Medical AirLife humidification chambers and heated breathing circuit kits over a manufacturing error that could cause the chamber to split and allow water into the patient’s breathing circuit.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The AirLife humidification chamber and heated breathing circuit kits are designed for use with invasive and non-invasive ventilation systems to provide humidified breathing gasses for adults and children, and are meant for use in hospitals and other health care settings under trained supervision, the federal watchdog said.
