FDA-Device2018-05-16Class I
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing 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.
Vyaire Medical
Hazard
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 the resuscitator.
Sold states
Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
Affected count
8,100 units
Manufactured in
75 N Fairway Dr, N/A, Vernon Hills, IL, United States
Products
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1562-2018Don't want to check this manually?
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