Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 6 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for resuscitation where a mechanical failure (mask sticking) poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Vyaire Medical is recalling 6 units of AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector, and manometer. The affected devices are manual resuscitation devices used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
The recall is due to a potential sticking condition in the mask component. This issue may result in a difficult or unable-to-disconnect condition of the mask from the elbow of the resuscitator.
The recalled products are identified by Part Number 2K8010C2M and Lot 0001015416. These devices were distributed worldwide, including in the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe.
The recalled product
- Product
- AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who a
- Manufacturer
- Vyaire Medical
- Affected units
- 6
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 (1)
- Part Number: 2K8010C2M. Lot: 0001015416
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 35 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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