FDA-Device2024-03-06Class I
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
Vyaire Medical
Hazard
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.
Sold states
Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
Affected count
1,800,000 units
Manufactured in
26125 N Riverwoods Blvd, Mettawa, IL, United States
Products
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1065-2024Don't want to check this manually?
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