Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 18 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 with a functional defect that could impede emergency ventilation, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Vyaire Medical is recalling 18 units of AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, and manometer. 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 these specific 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 affected units are identified by Part Number 2K8004C2M and Lot 0001022613. These devices were distributed worldwide, including in the United States, 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 instructions on how to proceed.
The recalled product
- Product
- AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer 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 adequate
- Manufacturer
- Vyaire Medical
- Affected units
- 18
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: 2K8004C2M
- Lot: 0001022613
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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