FDAFDA · Food and drugs·Recall number Z-1551-2018
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer 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.
Published May 16, 2018 · Recall initiated: April 27, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vyaire Medical
- Distributor
- Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
- Lot
- Part Number: 2K8004M, Lot: 0001025673
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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