AirLife Adult Manual Resuscitator Kits Recalled for Component Failure
Vyaire Medical is recalling 3,636 AirLife Adult Manual Resuscitator kits. Manufacturing defects can cause component failure that prevents proper ventilation, potentially resulting in fatal hypoxia.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall for a medical device whose manufacturing defect can prevent proper ventilation and cause potentially fatal hypoxia. No illnesses have been reported to date, but the hazard directly affects life-sustaining respiratory function.
Plain-English summary
Vyaire Medical is recalling AirLife Adult Manual Resuscitator kits (model REF 2K8004C2) because defective mold and tooling during manufacturing produced duckbill and ring components that do not meet specifications. These components can break or separate during use, preventing proper ventilation.
When the duckbill and ring components fail, the device cannot deliver adequate ventilation. This results in improper or absent ventilation, leading to hypoventilation and hypoxia, which can be fatal.
A total of 3,636 units are affected. The affected units have manufacturing dates of 2017 and earlier, or lack a recorded manufacturing date. These products have been distributed worldwide, including to the United States, Brazil, Canada, Switzerland, France, United Kingdom, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa.
The defective mold and tooling were replaced in 2017.
The recalled product
- Product
- AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
- Manufacturer
- Vyaire Medical
- Affected units
- 3,636
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: 50190752114119
- Each: 10190752114111
- All manufacturing dates of 2017 and prior
- and any products without a manufacturing date.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Vyaire Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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