Recall Z-1559-2018— Vyaire Medical
Class I · Terminated
Class I FDA medical device recall by Vyaire Medical, initiated 2017-04-27, terminated 2019-05-09. FDA's recall record names no specific 510(k) clearance for this event. Product: AirLife Resuscitation, Infant, 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 are not breathing or cannot adequately breathe on their own.. Reason: 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..
- Recalling firm
- Vyaire Medical
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-04-27
- Terminated
- 2019-05-09
- Firm location
- Vernon Hills, IL, United States
Product description
AirLife Resuscitation, Infant, 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 are not breathing or cannot adequately breathe on their own.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.