Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 180 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 with a mechanical defect that could impede the disconnection of a resuscitation mask. This represents a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Vyaire Medical is recalling 180 units of the AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, and PEEP valve. These manual resuscitation devices are 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 of the devices has been identified as having the potential to exhibit a sticking condition. This issue may result in a difficult or unable to disconnect condition of the mask from the elbow of the resuscitator.
The affected devices, identified by Part Number 2K8040 and Lot 0001073367, were distributed worldwide, including in the United States, Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cann
- Manufacturer
- Vyaire Medical
- Affected units
- 180
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: 2K8040. Lot: 0001073367
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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