Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 720 pediatric 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) could impede patient care, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vyaire Medical is recalling 720 units of AirLife Resuscitation, Pediatric devices. The recall involves specific lots (0001002934, 0001007292) with Part Number 2K8037. These 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 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. No specific instructions for consumers are provided in the source text, but the recall is managed by Vyaire Medical.
The recalled product
- Product
- AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, 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 brea
- Manufacturer
- Vyaire Medical
- Affected units
- 720
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 (2)
- Part Number: 2K8037. Lots: 0001002934
- 0001007292
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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