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Vyaire Medical recalls AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Recalled March 6, 2024 · FDA recall Z-1064-2024 · 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. · FDA Class I
Units
1,020,330 units
Sold at
Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
Description
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.
Product
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Manufacturer(s)
Vyaire Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →