Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 1,260 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 used for life-support ventilation where a mechanical failure (mask sticking) could impede patient care, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vyaire Medical is recalling 1,260 units of AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, and filter. 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 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 were distributed worldwide, including the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 2K8004F, and the affected lot numbers are 0000924948, 0000934061, 0000953218, 0000960729, 0000991584, 0001018701, and 0001025673. Users should check their devices for these lot numbers and contact the manufacturer for instructions.
The recalled product
- Product
- AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, 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 breathe on the
- Manufacturer
- Vyaire Medical
- Affected units
- 1,260
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 (8)
- Part Number: 2K8004F
- Lots: 0000924948
- 0000934061
- 0000953218
- 0000960729
- 0000991584
- 0001018701
- 0001025673
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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