BEUDAMED
    FDA Recall Terminated

    Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085

    Recall: Z-0901-04 · Initiated April 12, 2004

    Recall

    Recall Number
    Z-0901-04
    Event Number
    28762
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KPF--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2004
    Posted
    July 20, 2004
    Terminated
    February 26, 2008
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085

    Reason

    There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.

    Action

    Baxter sent Urgent Device Correction letters dated 4/12/04 to the attention of the Dialysis Unit Administrator. Separate letters were sent to the Renalsoft customers and to the Renal Software Suite customers. The letters described the software anomalies associated with the software and provided interim workaround instructions until permanent corrective actions to these anomalies can be identified.

    Distribution

    Nationwide

    Quantity

    4,148 units