Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 42 AirLife Pediatric 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 with a mechanical defect that could prevent disconnection during emergency ventilation. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Vyaire Medical is recalling 42 units of AirLife Resuscitation, Pediatric devices. 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 devices include a mask, 40-inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, and monometer.
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 units are identified by Part Number 2K8008C2M and Lots 0001022614 and 0001035872. The devices were distributed nationwide in the United States, as well as in Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. Consumers and healthcare providers should stop using the affected devices and contact Vyaire Medical for further instructions.
The recalled product
- Product
- AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who
- Manufacturer
- Vyaire Medical
- Affected units
- 42
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: 2K8008C2M. Lots: 0001022614
- 0001035872
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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