Vyaire Medical is pulling 6,633,173 AirLife Adult Manual Resuscitators after reports of patients not receiving enough — or any, in some cases — ventilation. As of March 21, 37 incidents, two injuries and two deaths have been reported in connection to the recall, the FDA said.
The product’s issue was traced to a manufacturing defect, which was corrected in 2017, but affected resuscitators may still be in use.
Vyaire Medical said the devices should not be returned, rather, customers were instructed to dispose of the resuscitators and inform the company.
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