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 o
Check against the official notice below — it lists the full affected range.
Vyaire Medical is recalling 8,058 AirLife Resuscitation pediatric devices with masks and 40-inch oxygen reservoir tubing due to a sticking condition in the mask component. This sticking can make it difficult or impossible to disconnect the mask from the elbow of the resuscitator. The affected devices have part number 2K8008 and were distributed worldwide to the United States, Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe across ten specific lot numbers.
The recall notice does not specify a remedy or recommended action for consumers with affected devices.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe. Quantity: 8,058 units Lot/code info: Part Number: 2K8008, Lots: 00010002841, 0001006156, 0001006158, 0001009054, 0001015412, 0001015413, 0001018698, 0001018699, 0001025674, 0001030572
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.