BEUDAMED
    FDA Recall Terminated

    Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090

    Recall: Z-0100-2008 · Initiated September 18, 2007

    Recall

    Recall Number
    Z-0100-2008
    Event Number
    44792
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1217052
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 18, 2007
    Posted
    November 7, 2007
    Terminated
    May 8, 2012
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090

    Reason

    Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.

    Action

    Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical.

    Distribution

    Nationwide.

    Quantity

    40 units