On January 30, 2018, Vyaire Medical recalled the AirLife Humidification Chamber and Heated Breathing Circuit Kits due to a manufacturing error that may cause parts of the chamber to split apart into layers, allowing water to overflow the chamber and to back up into the patient breathing circuit. If this occurs, an excessive amount of water could enter the airway or lungs of a ventilated patient and lead to serious adverse health consequences, including injury or death.
The AirLife Humidification Chamber and Heated Breathing Circuit Kit are used with invasive and non-invasive ventilation systems to provide constant humidified breathing gases for adults and children. The AirLife Humidification Chamber and Heated Breathing Circuit Kits are used in hospitals and other healthcare settings under the supervision of doctors and other trained healthcare providers.
The recalled items include lot codes AH290, AH132, AH265, AH202, and AH280. The recalled items were manufactured between May 18, 2017, and September 28, 2017, and distributed between July 3, 2017, and November 10, 2017.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe