BEUDAMED
    FDA Recall Terminated

    PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080

    Recall: Z-0569-04 · Initiated December 12, 2003

    Recall

    Recall Number
    Z-0569-04
    Event Number
    27986
    Firm
    Smiths Medical ASD, Inc.
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 12, 2003
    Posted
    July 20, 2004
    Terminated
    May 2, 2006
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080

    Reason

    Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm

    Action

    Smiths Medical contacted dealers via telephone on December 12, 2003. The direct customers to whom product was shipped contacted via a visit by the Smiths Medical sales representative Monday, December 15, 2003 through December 12,2 003.

    Distribution

    AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI

    Quantity

    30 CASES (2/CASE)