medical Class I Updated 2018-05-16

Vyaire Medical recalls AirLife Resuscitation, Adult, with mask, 28inch large bore t

Recalled Product

AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number: 2K8032. Lots: 0000911374, 0000917042, 0000921479, 0000924302, 0000929950, 0000933592, 0000944381, 0000949465, 0000963263, 0000966513, 0000966514, 0000969802
View official government recall

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