Vyaire Medical is recalling AirLife Humidification Chamber and Heated Breathing Circuit Kits used to provide constant humidified breathing gasses for adults and children because of a manufacturing error that poses serious and life threatening risks to patients. Medical facilities with units have been asked by the company to destroy the units immediately. A total of 16,670 units nationwide are affected.
The issue involves 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. As a result, the recall is classified as a Class I, the most serious type of recall under the Food and Drug Administration (FDA).
AirLife Humidification Chamber and Heated Breathing Circuit Kits are used in hospitals and other health care settings under the supervision of doctors and other trained health care providers. Affected units were distributed from July 3, 2017, to Nov. 10, 2017. Model and item numbers and codes of affected units can be found on Vyaire Medical’s recall notice.
Medical facilities that have affected AirLife units have been sent an Urgent Recall Notification letter with instructions to destroy all affected products in stock in accordance with their facility’s destruction protocol.
Any adverse events related to the AirLife Humidification Chamber and Heated Breathing Circuit Kits should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice