Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 498 pediatric AirLife 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 life-sustaining ventilation where a mechanical failure (mask sticking) could prevent proper use or disconnection, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Vyaire Medical is recalling 498 units of AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, and PEEP valve. The devices are manual resuscitation tools 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 products are identified by Part Number 2K8039 and Lots 0001002932 and 0001018700. The devices were distributed nationwide in the United States and in Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. Users should stop using the affected devices and contact Vyaire Medical for instructions on how to proceed.
The recalled product
- Product
- AirLife Resuscitation, Pediatric, 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 c
- Manufacturer
- Vyaire Medical
- Affected units
- 498
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 (2)
- Part Number: 2K8039. Lots: 0001002932
- 0001018700
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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