AirLife Adult Manual Resuscitator recalled for ventilation failure risk
Vyaire Medical is recalling 4,572 units of AirLife Adult Manual Resuscitators due to defective components that may cause improper ventilation or complete ventilation failure, potentially resulting in hypoventilation, hypoxia, or death.
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: This recall receives a Severe rating due to FDA Class I classification, which indicates a serious risk of adverse health consequences. Although no deaths or injuries have been reported, the recalled device is a manual resuscitator—a critical life-support tool—and the manufacturing defect could prevent proper ventilation, potentially resulting in hypoventilation, hypoxia, or death.
Plain-English summary
Vyaire Medical is recalling 4,572 units of the AirLife Adult Manual Resuscitator with 40" Oxygen Reservoir Tubing, Adult Mask, and CO2 Detector (REF 2K8005C2) due to a manufacturing defect in the duckbill and ring components.
The duckbill and ring components may break or disassemble due to faulty mold and tooling used in manufacturing. When these components fail, the device may not deliver proper ventilation or may fail to ventilate entirely. This failure may result in hypoventilation or hypoxia and could potentially lead to death.
The affected units include all products manufactured in 2017 or earlier, and any products without a manufacturing date. The devices have been distributed worldwide, including throughout the United States, Brazil, Canada, Switzerland, France, United Kingdom, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa.
Consumers and healthcare facilities using affected units should immediately discontinue use and contact Vyaire Medical for a replacement or guidance. Healthcare providers should inspect their equipment to verify manufacturing dates and UDI codes (Case: 50190752114164, Each: 10190752114166).
The recalled product
- Product
- AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
- Manufacturer
- Vyaire Medical
- Affected units
- 4,572
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: 50190752114164
- Each: 10190752114166
- 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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