AirLife manual resuscitator component defect risks ventilation failure
Vyaire Medical is recalling AirLife Adult Manual Resuscitators with defective duckbill and ring components that may fail to provide ventilation, risking hypoventilation or hypoxia. The defect affects units manufactured in 2017 and earlier.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall where component failure may result in hypoventilation, hypoxia, and potential death. FDA Class I designation mandates a minimum severity score of 4.
Plain-English summary
Vyaire Medical is recalling 2,070 units of the AirLife Adult Manual Resuscitator, including a 40-inch oxygen reservoir tubing, adult mask, and expiratory filter (model REF 2K8005F). The duckbill and ring components in the device may break or disassemble due to faulty manufacturing tooling used to produce them, resulting in out-of-specification components.
If these components fail, the resuscitator may not deliver proper ventilation or may fail to deliver any ventilation at all. This can cause hypoventilation or hypoxia, which can potentially lead to death.
The recall affects devices manufactured in 2017 and earlier, as well as any devices without a manufacturing date. Affected units have been distributed worldwide, including throughout the United States, Brazil, Canada, Switzerland, France, the United Kingdom, Mexico, the Netherlands, Saudi Arabia, Sweden, and South Africa. The affected UDI/DI Case number is 50190752114188, with individual unit code 10190752114180.
Healthcare facilities and individuals using this device should immediately discontinue use and contact Vyaire Medical for replacement or instructions. The manufacturing tooling was replaced in 2017, so units manufactured after 2017 are not affected by this defect.
The recalled product
- Product
- AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
- Manufacturer
- Vyaire Medical
- Hazard
- component-failure
- hypoventilation
- hypoxia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI Case: 50190752114188
- Each: 10190752114180
- All manufacturing dates of 2017 and prior
- and any products without a manufacturing date.
Distribution
Distributed nationwide across the United States.
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