Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,058 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class I recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity score for minor defects or documentation issues.
Plain-English summary
Vyaire Medical is recalling 8,058 units of AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, and pressure-relief valve. 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 various lots has been identified as having the potential to exhibit a sticking condition. This defect 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 2K8008, and the affected lots are 00010002841, 0001006156, 0001006158, 0001009054, 0001015412, 0001015413, 0001018698, 0001018699, 0001025674, and 0001030572. Users should check their devices against these lot numbers and contact the manufacturer for instructions.
The recalled product
- Product
- AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve 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 can
- Manufacturer
- Vyaire Medical
- Hazard
- Affected units
- 8,058
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 (11)
- Part Number: 2K8008
- Lots: 00010002841
- 0001006156
- 0001006158
- 0001009054
- 0001015412
- 0001015413
- 0001018698
- 0001018699
- 0001025674
- 0001030572
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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