Description of Event or Problem · 1
THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATHE ATOMIZER ON (B)(6) 2013. SHE REPORTED THAT A WASHER FELL FROM THE EZ BREATHE ATOMIZER INTO HER MOUTH SIX MONTHS AGO DURING USE. THE PT WAS ABLE TO RETRIEVE THE COMPONENT WITHOUT REQUIRING ANY MEDICAL INTERVENTIONS. THE PT IS A (B)(6) YEAR OLD FEMALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. SHE REPORTS THAT SHE IS ALLERGIC TO SULFA DRUGS AND IS A CURRENT SMOKER. THE INVESTIGATED PRODUCT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MANUFACTURER HEALTH & LIFE, CO., LTD., ON MAY 8, 2013. THE CLASS I RECALL (Z-1371-2013, Z-1372-2013, Z-1373-2013) WAS INITIATED AFTER NEPHRON PHARMACEUTICALS CORPORATION, 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).