Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 4,640 AirLife Infant 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 4,640 units of AirLife Resuscitation, Infant devices, part number 2K8010BR. 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 affected lots are 0000890355, 0000890357, 0000890358, 0000940369, 0000994501, 0001061390, 0001064441, and 0001092070.
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 devices were distributed worldwide, including in the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. Users should check their devices for the affected part number and lot numbers listed above.
The recalled product
- Product
- AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing
- Manufacturer
- Vyaire Medical
- Affected units
- 4,640
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: 2K8010BR. Lots: 0000890355
- 0000890357
- 0000890358
- 0000940369
- 0000994501
- 0001061390
- 0001064441
- 0001092070
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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