BEUDAMED
    FDA Recall Terminated

    Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter

    Recall: Z-2191-2008 · Initiated April 24, 2008

    Recall

    Recall Number
    Z-2191-2008
    Event Number
    48642
    Firm
    Cook Vascular Inc.
    FEI Number
    2522007
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 24, 2008
    Posted
    September 17, 2008
    Terminated
    September 18, 2008
    Address
    1186 Montgomery Ln, Vandergrift, PA, 15690-6065

    Description

    Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter

    Reason

    mislabeled - wrong size catheter was packaged in the box

    Action

    The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.

    Distribution

    The products were shipped to distributors in Japan and Brazil.

    Quantity

    20 units