Vyaire Medical Inc is recalling sure AirLife handbook resuscitators for a producing defect that might result in damage or dying, in response to the FDA. The recall is classed as Class I.
The FDA recall alert stories that utilizing the recalled resuscitators may lead to sufferers not receiving sufficient air flow, and in some instances, sufferers could not obtain any air flow. Sufferers who don’t get satisfactory air flow could expertise hypoventilation or hypoxia, which might result in critical damage or dying, the FDA stories.
In keeping with the FDA, there have been 37 reported incidents associated to the recalled AirLife resuscitators, together with two accidents and two deaths. The company says the problem was traced to a producing defect that was corrected in 2017, however resuscitators distributed earlier than the correction should still be in use.
Recalled Merchandise
- Product Names and Codes:
- AirLife™ Grownup Guide Resuscitator, Oxygen Reservoir Bag, with out Masks, 2K8000
- AirLife™ Grownup Guide Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, with out Masks, 2K8001
- AirLife™ Grownup Guide Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, 2K8004F
- AirLife™ Grownup Guide Resuscitator, Oxygen Reservoir Bag, Grownup Masks, CO2 Detector, 2K8004C2
- AirLife™ Grownup Guide Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, Grownup Masks, 2K8005
- AirLife™ Grownup Guide Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, Grownup Masks, Expiratory Filter, 2K8005F
- AirLife™ Grownup Guide Resuscitator, 40″ (1.0 m) Oxygen Reservoir Tubing, Grownup Masks, CO2 Detector, 2K8005C2
- AirLife™ Grownup Guide Resuscitator, Variable Quantity Oxygen Reservoir Tubing, Grownup Masks, 2K8017
- AirLife™ Grownup Guide Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, Grownup Masks, 2K8004
- Manufacturing Dates: 2017 or earlier and merchandise and not using a manufacturing date
- Gadgets Recalled within the US: 6,633, 173
- Date Initiated by Agency: December 6, 2023
The AirLife model of merchandise was acquired from Vyaire in Could 2023 by SunMed, which rebranded its firm as “AirLife” in September 2023. The merchandise topic to this recall are these manufactured in 2017 or earlier, the FDA famous.
The FDA directs US prospects to contact Vyaire Medical Inc at [email protected].
Supply: FDA
