Vyaire Medical AirLife Manual Resuscitators Recalled
Vyaire Medical Inc. has issued a recall for certain models of AirLife Manual Resuscitators manufactured in or before 2017. The recall has been categorized as a Class I recall by the U.S. Food and Drug Administration, indicating that use of the recalled devices may result in serious injury or death.
Due to a manufacturing defect, the resuscitators may fail to provide adequate ventilation as intended. The recalled devices have been associated with multiple injuries, including at least two deaths.
Up to 6.6 million units of the devices were manufactured in or before 2017 and may have been stocked in hospitals, healthcare facilities and ambulances. Healthcare facilities or organizations who purchased the devices may be at risk of financial loss due to the recall and may be eligible for compensation.
AirLife Manual Resuscitator Models Recalled
The Vyaire AirLife Manual Resuscitator recall has listed devices manufactured in or before 2017 including models:
- AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, 2K8000
- AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, without Mask, 2K8001
- AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, 2K8004F
- AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, 2K8004C2
- AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, Adult Mask, 2K8005
- AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, 2K8005F
- AirLife™ Adult Manual Resuscitator, 40″ (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, 2K8005C2
- AirLife™ Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, 2K8017
- AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, Adult Mask, 2K8004
Hospitals, healthcare facilities and ambulances who stock the AirLife resuscitators have been advised to discontinue using and remove any of the devices manufactured in or before 2017 from their stock. Some of the resuscitators may not have a manufacturing date listed and should also be considered part of the recall.
AirLife Manual Resuscitators Failure May Pose Serious Risks
AirLife Manual Resuscitators are a type of medical device known as bag-valve masks and are used by emergency personnel during medical emergencies which require resuscitation. Bag-valve masks are single use devices used to force air into the lungs when a patient has inadequate breathing or has suffered respiratory arrest.
At least 37 incidents involving AirLife Manual Resuscitator have been reported to the FDA, including two injuries and two deaths. The Vyaire Medical AirLife Manual Resuscitator recall has been classified as Class I, indicating that use of the devices may cause serious injuries or death.
The recalled AirLife devices may have a manufacturing defect which prevents them from providing adequate ventilation. Patients who are not adequately ventilated may suffer from lack of oxygen (hypoxia) and elevated carbon dioxide levels which may lead to serious injury, or even death.
The manufacturing defect was corrected in 2017 but the devices were not recalled at that time and may still be stocked in some ambulances, emergency rooms and healthcare facilities. Facilities and professionals have been advised to discontinue using the devices and remove them from stock.
Hospitals and Ambulances May be at Risk of Financial Loss
Up to 6.6 million units may be affected in the Vyaire AirLife Manual Resuscitator recall. This may leave many healthcare organizations with unusable stock they purchased and in search of replacements at a greater cost.
In addition to the financial costs of sourcing new equipment to replace recalled stock, treatment failures caused by defective devices may place healthcare providers and organizations at risk of financial loss.
Vyaire did not notify customers until January 2024 and has instructed those impacted to document destruction of the devices but has not offered compensation nor addressed additional risks that healthcare providers may face.
Hospitals, Healthcare Facilities and Ambulance Services who stocked Vyaire AirLife Manual Resuscitators and were affected by the resuscitator recall may have been placed at risk and may be eligible for compensation.