Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 20 AirLife Resuscitation Broselow Hinkle Kits because the mask component may stick, making it difficult to disconnect from the device.
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 20 units of the AirLife Resuscitation Broselow Hinkle Kit. 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 were distributed worldwide, including in the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 7730IALS, and the affected lot numbers are 0000996572, 0001011800, and 0001082819. Users should stop using the affected devices and contact Vyaire Medical for further instructions.
The recalled product
- Product
- AirLife Resuscitation, Broselow Hinkle Kit 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 own.
- Manufacturer
- Vyaire Medical
- Affected units
- 20
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 (3)
- Part Number: 7730IALS. Lots: 0000996572
- 0001011800
- 0001082819
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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