Description of Event or Problem · 1
THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6), 2013. HE REPORTED THAT A WASHER FELL FROM THE EZ BREATHE ATOMIZER ALONG WITH THE ASTHMANEFRIN INHALATION SOLUTION INTO HIS THROAT. HE REPORTED THAT HE ALSO EXPERIENCED THROAT IRRITATION AND WAS ADVISED BY A PHYSICIAN TO MONITOR HIS SYMPTOMS. THE INVESTIGATED PRODUCT FOR THE ENCLOSED MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MANUFACTURER HEALTH & LIFT, CO., LTD., ON MAY 08, 2013. THE CLASS 1 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).