Home / Recalls / Medical Devices
Vyaire Medical recalls AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation
Recalled May 16, 2018 · FDA recall Z-1578-2018 · 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. · FDA Class I
Units
20 units
Sold at
Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
Description
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.
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(s)
Vyaire Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →