medical Class I Updated 2018-05-16

Vyaire Medical recalls AirLife Resuscitation, Broselow Hinkle Kit Product Usage:

Recalled 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.


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: 7730IALS. Lots: 0000996572, 0001011800, 0001082819
View official government recall

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