BEUDAMED
    FDA Recall Terminated

    Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.

    Recall: Z-0947-05 · Initiated October 3, 2003

    Recall

    Recall Number
    Z-0947-05
    Event Number
    31870
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 3, 2003
    Posted
    June 30, 2005
    Terminated
    July 1, 2005
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.

    Reason

    The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.

    Action

    No official recall notificaiton was made. Meridian software version 4.12 was released on 10/3/03 and was implemented as a reliability improvement initiative to all Meridian customers. Shipment of 4.12 software was completed in November 2003.

    Distribution

    Nationwide, Korea, Mexico, Guatemala, China and Hong Kong

    Quantity

    2986 units