BEUDAMED
    FDA Recall Terminated

    Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090

    Recall: Z-0869-05 · Initiated May 16, 2005

    Recall

    Recall Number
    Z-0869-05
    Event Number
    32079
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1217052
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 16, 2005
    Posted
    June 4, 2005
    Terminated
    May 8, 2012
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090

    Reason

    Guiding catheter may have thinner and weaker sidewalls than designed, and may break.

    Action

    Smith Medical ASD initiated recall by letter on/about about May 16, 2005.

    Distribution

    Natiowide Foreign: Canada, Mexico and East Timor.