Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 54 AirLife 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 the mask from disconnecting, posing a risk of harm to patients during resuscitation, but no injuries or illnesses have been reported.
Plain-English summary
Vyaire Medical is recalling 54 units of AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, and filter. The recalled 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 was initiated because the mask component on various lots of these 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 2K8005F and Lot 0001022611. These devices were distributed worldwide, including in the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter 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 cannot adequately brea
- Manufacturer
- Vyaire Medical
- Affected units
- 54
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: 2K8005F
- Lot: 0001022611
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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