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Recall Observatory FDA recall evidence

Device product

AirLife Resuscitation, Infant, 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.

Z-1564-2018

April 27, 2017

Class I

Product summary

Firm
Vyaire Medical
Event
Event 78412
Status
Terminated
Classification
Class I
Quantity
2,262 units
Official record key
device-enforcement:Z-1564-2018

Official wording

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.

Code information: Part Number: 2K8019. Lots: 0001006159, 0001010401, 0001034518, 0001034519, 0001040641, 0001040642

Distribution pattern: Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.