Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 4,500 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 functional defect that could impede emergency ventilation, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Vyaire Medical is recalling 4,500 units of AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, and PEEP valve. 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 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 products are distributed worldwide, including in the United States, Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 2K8036, and the affected lots are 0001022608, 0001022609, and 0001025672. Users should check their devices for these lot numbers and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, 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 cannot adequately
- Manufacturer
- Vyaire Medical
- Affected units
- 4,500
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 (3)
- Part Number: 2K8036. Lots: 0001022608
- 0001022609
- 0001025672
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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