BEUDAMED
    FDA Recall Terminated

    NxStage Cartridge Express, CAR-170, for hemodialysis.

    Recall: Z-1228-2007 · Initiated July 27, 2007

    Recall

    Recall Number
    Z-1228-2007
    Event Number
    38546
    Firm
    NxStage Medical, Inc.
    FEI Number
    3003464075
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    July 27, 2007
    Posted
    September 20, 2007
    Terminated
    September 13, 2010
    Address
    439 South Union Street, Floor 5th, Lawrence, MA, 01843-2800

    Description

    NxStage Cartridge Express, CAR-170, for hemodialysis.

    Reason

    Potential for dialysate leaks from the cartridge during treatment.

    Action

    NxStage initiated the recall by letter on 8/24/07 advising users of the specific lots to be removed from use. Prior notifications were issued on July 27, 2007, July 30, 2007 and July 31, 2007 notifying users of the potential for leaks and instructions to detect leaks prior to use.

    Distribution

    Nationwide

    Quantity

    12,085 cases