Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,124 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible 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 with a mechanical defect that could prevent disconnection during use, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Vyaire Medical is recalling 8,124 units of AirLife Resuscitation, Infant devices. The recall involves specific lots of the manual resuscitation devices used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
The recall was initiated because the mask component on various lots has been identified as having the potential to exhibit a sticking condition. This defect may result in a difficult or unable to disconnect condition of the mask from the elbow of the resuscitator.
The affected devices were distributed worldwide, including the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. Consumers and healthcare providers should stop using the affected devices and contact Vyaire Medical for instructions on how to proceed.
The recalled product
- Product
- AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are
- Manufacturer
- Vyaire Medical
- Affected units
- 8,124
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 (13)
- Part Number: 2K8010. Lot: 0001007295
- 0001015414
- 0001018697
- 0001022519
- 0001022518
- 0001034530
- 0001040652
- 0001040653
- 0001043846
- 0001043847
- 0001044102
- 0001064454
- 0001067498
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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