Urgent Safety Notice concerning Filter for dialysate purification EF-02D, Nikkiso
2011.07.12
Product group Injections / Infusions / Transfusions / Dialysis
Reference 02448/11
The company Nikkiso Co., Ltd. notified of an update of the Urgent Field Safety Notice that was issued in Nov 2010 about the risk that EF-02D dialysate purification filters for DBB05/DBB06 machines may leak (case 3976/10).
Filters with a modified housing design are expected to be available from Sept 2011. In the interim 2 advices to desinfection and dialysate flow have to be followed.
The instructions for use have been updated and are attached to the safety advice.