Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 42 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of…"
Plain-English summary
Vyaire Medical is recalling 42 units of AirLife Resuscitation, Pediatric devices. 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 devices include a mask, 40-inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, and monometer.
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 units are identified by Part Number 2K8008C2M and Lots 0001022614 and 0001035872. The devices were distributed nationwide in the United States, as well as in 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 further instructions.
The recalled product
- Product
- AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who…
- Manufacturer
- Vyaire Medical
- Affected units
- 42
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: 2K8008C2M. Lots: 0001022614
- 0001035872
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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