BEUDAMED
    FDA Recall Terminated

    Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034

    Recall: Z-0017-05 · Initiated September 20, 2004

    Recall

    Recall Number
    Z-0017-05
    Event Number
    30007
    Firm
    Fresenius Medical Care North America
    FEI Number
    3001451489
    Product Code
    KDJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 20, 2004
    Posted
    October 13, 2004
    Terminated
    June 28, 2006
    Address
    95 Hayden Ave, Lexington, MA, 02421-7942

    Description

    Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034

    Reason

    Peritoneal Dialysis Transfer Set may have occluded pathway

    Action

    Fresenius Medical is conducting telephone contact to the dialysis clinics starting 9/20/04 and follow-up with a notice to be mailed o/a 9/27/04.Clinics are requested to examine inventory for lot numbers and return unused product to Fresenius.

    Distribution

    Nationwide Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON

    Quantity

    3,510 units