Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 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 (sticking mask) could impede patient care, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vyaire Medical is recalling specific lots of AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, and PEEP valve devices. 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 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 distributed worldwide, including in the United States, Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 2K8035, and the affected lots are 001022606, 0001034508, and 0001034509. A total of 3,600 units are involved in this recall.
The recalled product
- Product
- AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, 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 breathe on
- Manufacturer
- Vyaire Medical
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: 2K8035. Lots: 001022606
- 0001034508
- 0001034509
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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