Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,100 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as a situation where use of the product is not likely to cause adverse health consequences.
Plain-English summary
Vyaire Medical is recalling 8,100 units of AirLife Resuscitation, Adult, with mask, 28inch large bore tubing. 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 issued 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 were distributed worldwide, including in the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 2K8017, and the affected lots are 0001022516, 0001025656, 0001025655, 0001029028, and 0001040668.
The recalled product
- Product
- AirLife Resuscitation, Adult, with mask, 28inch large bore tubing 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 their o
- Manufacturer
- Vyaire Medical
- Hazard
- Affected units
- 8,100
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 (5)
- Part Number: 2K8017. Lots: 0001022516
- 0001025656
- 0001025655
- 0001029028
- 0001040668
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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