Vyaire Medical Recalls AirLife Resuscitation Replacement Kits Due to Mask Sticking
Vyaire Medical is recalling 150 AirLife Resuscitation replacement kits because the mask component may stick to the elbow, preventing disconnection.
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 use. 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 150 units of the AirLife Resuscitation Replacement kit for the outer shell, specifically for the Broselow device. 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 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 products are identified by Part Number 7730POCH and Lots 0000993427 and 0001069517. The products were distributed worldwide, including the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- AirLife Resuscitation, Replacement kit for outer shell, 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 or cannot adequately breathe on their ow
- Manufacturer
- Vyaire Medical
- Affected units
- 150
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: 7730POCH. Lots: 0000993427
- 0001069517
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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