Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 305,136 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 defect could prevent the device from being disconnected, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Vyaire Medical is recalling 305,136 units of AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing. The devices are manual resuscitation tools 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 the devices 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 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 2K8005, and the recall covers numerous specific lot numbers listed in the agency's records.
The recalled product
- Product
- AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs 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
- Affected units
- 305,136
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 (20)
- Part Number: 2K8005
- Lots: 0000908575
- 0000909893
- 0000909894
- 0000911377
- 0000911378
- 0000911379
- 0000913867
- 0000912890
- 0000913868
- 0000915438
- 0000915439
- 0000915440
- 0000915441
- 0000915442
- 0000915443
- 0000917043
- 0000917045
- 0000917047
- 0000917049
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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