Medical Device Recall: AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Vyaire Medical · January 10, 2024
Reason for Recall
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.
Distribution
Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
States Affected
NATIONWIDE
Quantity Affected
1,020,330 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1064-2024
Status: ongoing
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