BEUDAMED
    FDA Recall Terminated

    The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK.

    Recall: Z-1384-04 · Initiated July 23, 2004

    Recall

    Recall Number
    Z-1384-04
    Event Number
    29663
    Firm
    Medtronic Inc, Neurological & Spinal Division
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 23, 2004
    Posted
    August 24, 2004
    Terminated
    November 23, 2005
    Address
    800 53rd Ave Ne, Columbia Heights, MN, 55421-1241

    Description

    The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK.

    Reason

    The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293.

    Action

    The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of manufactured product: CS0293.

    Distribution

    US and one customer in New Zealand.

    Quantity

    405 kits