AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation
Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.
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: The device is classified as FDA Class I, which requires a minimum severity of Severe. Although no injuries or deaths have been reported, component failure directly prevents adequate oxygen delivery, potentially causing hypoxia and death in a critical emergency ventilation device.
Plain-English summary
Vyaire Medical is recalling 66,078 units of the AirLife Adult Manual Resuscitator oxygen reservoir tubing (40 inches, REF 2K8001) manufactured in 2017 or earlier, or any units without a manufacturing date. The product has been distributed worldwide, including to healthcare facilities in the United States, Brazil, Canada, Switzerland, France, United Kingdom, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa.
The duckbill valve and ring components in affected units may break or separate from the assembly due to manufacturing defects in the mold and tooling used to produce these parts. The defective mold and tooling were replaced in 2017.
Device failure in these units can result in improper ventilation or complete loss of ventilation to patients. This may lead to hypoventilation (inadequate breathing) and hypoxia (oxygen deprivation), potentially causing serious injury or death.
The recalled product
- Product
- AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
- Manufacturer
- Vyaire Medical
- Hazard
- device-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: 50190752114096
- Each: 10190752114098
- 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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