Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking Issue
Vyaire Medical is recalling 797 AirLife Resuscitation Broselow Hinkle Kits because the mask 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: This is a Class I recall for a medical device used in emergency resuscitation. The hazard involves a mechanical failure that could prevent the device from being disconnected, posing a risk of harm to patients, although no specific injuries are reported in the source text.
Plain-English summary
Vyaire Medical is recalling 797 units of AirLife Resuscitation Broselow Hinkle Kits. 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 units were distributed nationwide in the United States, as well as in Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe.
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 product is identified by Part Number 7730ALS. The specific lot numbers involved are 0000993426, 0000994766, 0000996685, 0001011762, 0001011763, 0001017478, 0001026192, 0001026868, 0001028306, 0001031760, 0001032932, 0001048406, and 0001082823. Users should check their devices for these part and lot numbers and contact the manufacturer 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
- 797
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 (13)
- Part Number: 7730ALS. Lots: 0000993426
- 0000994766
- 0000996685
- 0001011762
- 0001011763
- 0001017478
- 0001026192
- 0001026868
- 0001028306
- 0001031760
- 0001032932
- 0001048406
- 0001082823
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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