Vyaire Medical 2024-03-06 Health critical FDA
Health · FDA · Recall #FDA-Z-1062-2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask,… Recall
Issued March 6, 2024 · Vyaire Medical
In March 2024, Vyaire Medical recalled the AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask,…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
What you should do
- 1 Stop using AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Vyaire Medical to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Vyaire Medical
- Category
- Health
- Recall date
- March 6, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
- Recall number
- FDA-Z-1062-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Vyaire Medical has 1 recall in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.