FDA (Devices) recall action 78412

Vyaire Medical recalled 35 products on 2018-05-16

The FDA (Devices) publishes a recall like this one as 35 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 35 pages.

Products: 35
Announced: 2018-05-16
Critical: 0
Units: 380,829

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–35 of 35

HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 2,982 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP 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 adequat
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 180 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathin
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 30 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
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
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 17,172 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, 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 adequa
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 42 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who
Category
Distribution
0 states
LowFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,100 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing 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 o
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 20 AirLife Resuscitation Broselow Hinkle Kits because the mask component may stick, making it difficult to disconnect from the device.
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.
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 4,640 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 54 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter 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 brea
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 4,500 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP 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
Category
Distribution
0 states