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.

1–25 of 35

HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 2,340 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, 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 ad
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 498 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, 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 c
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, oxygen reservoir bag, pressure-relief valve, 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 cann
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 720 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, 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 brea
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking Issue
Vyaire Medical is recalling 797 AirLife Resuscitation Broselow Hinkle Kits because the mask may stick to the elbow, preventing disconnection.
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 8,124 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, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 2,262 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.
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 adequ
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 270 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, 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 bre
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 24 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter 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 24 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 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
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 1,140 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, 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 breath
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitators Due to Mask Sticking
Vyaire Medical is recalling 198 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, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who ar
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitators Due to Mask Sticking
Vyaire Medical is recalling 3,600 AirLife Infant Resuscitators because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, 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 adequatel
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 305,136 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs 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 Replacement Kits Due to Mask Sticking
Vyaire Medical is recalling 150 AirLife Resuscitation replacement kits because the mask component may stick to the elbow, preventing disconnection.
Product
AirLife Resuscitation, Replacement kit for outer shell, 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 or cannot adequately breathe on their ow
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 6 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who a
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 18 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, 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 adequate
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 900 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, 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 breathi
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 180 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, 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
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 1,800 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, 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 Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 1,260 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, 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 breathe on the
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 24 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not bre
Category
Distribution
0 states
LowFDA (Devices)··2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,058 pediatric AirLife 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 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 can
Category
Distribution
0 states
HighFDA (Devices)··2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 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, 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 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 5,400 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 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