Vyaire Medical Recalls AirLife Infant Resuscitators Due to Mask Sticking
Vyaire Medical is recalling 198 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
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 used for life-support ventilation where a mechanical failure (mask sticking) poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Vyaire Medical is recalling 198 units of AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, and PEEP valve. The recall involves specific lots identified by part number 2K8038M.
The recall was initiated because the mask component on these devices has 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. These 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 affected units were distributed worldwide, including in the United States (nationwide), 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 instructions on how to proceed.
The recalled product
- Product
- AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who ar
- Manufacturer
- Vyaire Medical
- Affected units
- 198
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 (5)
- Part Number: 2K8038M. Lots: 0001045566
- 0001074625
- 0001080151
- 0001083196
- 0001086176
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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