AirLife Adult Manual Resuscitator units recalled for component failure
Vyaire Medical is recalling 106,656 units of AirLife Adult Manual Resuscitator bags due to faulty components that may break during use, causing ventilation failure and potentially leading to 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: FDA Class I medical device recall for component malfunction with potential to cause hypoventilation and hypoxia. Although device failure could potentially lead to death, no deaths or injuries have been reported to date.
Plain-English summary
Vyaire Medical is recalling AirLife Adult Manual Resuscitator bags (model REF 2K8000) due to faulty manufacturing of critical components. The duckbill and ring components were produced with defects resulting from faulty mold and tooling, creating out-of-specification parts. This recall affects approximately 106,656 units distributed worldwide, including the United States, Brazil, Canada, Switzerland, France, United Kingdom, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa.
The faulty components may break or disassemble during use, preventing proper ventilation and oxygen delivery. Device failure could result in hypoventilation or hypoxia. In severe cases, inadequate ventilation may potentially lead to death. No deaths or injuries have been reported to date.
Affected units were manufactured in 2017 or earlier, or carry no manufacturing date. Device identification: UDI Case 50190752114089; Unit UDI 10190752114081. Do not use resuscitators matching these criteria. Contact Vyaire Medical or your healthcare provider immediately for guidance on replacement or appropriate next steps.
The recalled product
- Product
- AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
- Manufacturer
- Vyaire Medical
- Hazard
- component-malfunction
- 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: 50190752114089
- Each: 10190752114081
- 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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