According to the FDA, Vyaire Medical, Inc. has recalled nine (9) AirLife Adult Manual Resuscitators because the products were found to have a manufacturing defect that poses a risk of serious injuries or death to its users.
Initiated by the company on December 6, 2023, the Class I recall, the most serious type, covers 6,633,173 devices across the U.S. Affected products include those that were manufactured in 2017 or earlier, as well as those products that do not bear a manufacturing date:
- 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
As a resuscitator used by a single patient for respiratory support, the Airlife Manual Resuscitator was recalled by Vyaire Medical, Inc. after a manufacturing defect was discovered. Officials say use of the now-recalled devices puts patients at risk of either not receiving adequate ventilation or any ventilation. Inadequate ventilation could prevent a patient from properly exchanging oxygen and carbon dioxide, resulting in hypoventilation. Patients could also suffer a blood oxygen drop (hypoxia). Both conditions could cause a patient to experience major injury or death.
At the time of the FDA announcement, Vyaire Medical has received 37 reports detailing incidents connected to the recalled resuscitators. Of those reports, two injuries and two deaths were recorded.
An investigation has determined that the issue is connected to a manufacturing defect which was amended in 2017. However, officials are warning customers and distributors against use of a number of resuscitators that were distributed before the product correction.
An urgent customer notification letter sent by Vyaire to customers and distributors on January 10, 2024 addressed customers who may still be in possession of AirLife manual resuscitators covered in the recall. The following requests were outlined:
- Dispose of, or destroy any recalled AirLife manual resuscitators
- Fill out a Certificate of Destruction Form and submit it to Vyaire via productquality@myairlife.com.
Consumers should note that Vyaire is not conducting a return program, and that any recalled resuscitators should not be sent back to the company.
Those in the U.S. may address additional questions to Vyaire Medical, Inc. via productquality@myairlife.com.
As the FDA continues to monitor the issue, healthcare professionals and consumers are asked to report any related adverse experiences to the agency’s MedWatch program.
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