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Recall Observatory FDA recall evidence

Device product

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir 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-1554-2018

April 27, 2017

Class I

Product summary

Firm
Vyaire Medical
Event
Event 78412
Status
Terminated
Classification
Class I
Quantity
8,058 units
Official record key
device-enforcement:Z-1554-2018

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: 2K8008, Lots: 00010002841, 0001006156, 0001006158, 0001009054, 0001015412, 0001015413, 0001018698, 0001018699, 0001025674, 0001030572

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.