Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 17,172 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-support ventilation where a mechanical failure (mask sticking) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Vyaire Medical is recalling 17,172 units of AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve. 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 were distributed worldwide, including the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 2K8032, and the affected lots are 0000911374, 0000917042, 0000921479, 0000924302, 0000929950, 0000933592, 0000944381, 0000949465, 0000963263, 0000966513, 0000966514, and 0000969802.
The recalled product
- Product
- AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief 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 adequa
- Manufacturer
- Vyaire Medical
- Affected units
- 17,172
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 (12)
- Part Number: 2K8032. Lots: 0000911374
- 0000917042
- 0000921479
- 0000924302
- 0000929950
- 0000933592
- 0000944381
- 0000949465
- 0000963263
- 0000966513
- 0000966514
- 0000969802
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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