Description of Event or Problem · 1
THE CUSTOMER CONTACTED (B)(4) REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. SHE REPORTED THAT A SILVER RING FELL FROM THE EZ BREATHE ATOMIZER AND LANDED ON HER TONGUE WHILE INHALING FROM THE DEVICE. NO MEDICAL INTERVENTIONS WERE REQUIRED TO RETRIEVE THE COMPONENT. THE INVESTIGATED PRODUCT FOR THE ENCLOSED MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MANUFACTURER HEALTH AND LIFE, CO., LTD., ON (B)(4) 2013. THE CLASS 1 RECALL (Z-1371-2013, Z-1372-2013, Z-1373-2013) WAS INITIATED AFTER (B)(4), THE IMPORTER, BECAME AWARE OF AN INCREASING NUMBER OF COMPLAINTS ASSOCIATED WITH THE POSSIBILITY OF A QUARTER-INCH WASHER BECOMING DISLODGED FROM THE EZ BREATHE ATOMIZER. THE IMPACTED ATOMIZER SERIAL NUMBER RANGES ARE: (B)(4).