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FDA recall of Vyaire AirLife humidification chambers is Class I

The 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. Vyaire Medical is reportedly recalling the devices due to manufacturing errors that could cause parts of the chamber to split into layers and allow water to overflow the chamber and back into the patient’s breathing circuit. If a patient is using the device when the error occurs, it could lead to an excessive amount of water entering the airway or lungs of the ventilated patient which could lead to serious adverse health consequences including death, according to the FDA. A total of 16,670 units are affected by the recall, with lot codes AH290, AH132, AH265, AH202 and AH280, manufactured between May 18, 2017 and Sept. 28, 2017 and distributed between July 3, 2017 and Nov. 10, 2017, accordi...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Recalls Respiratory Vyaire Medical Source Type: news

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