BEUDAMED
    FDA Recall Terminated

    BD K-3000 Microkeratome Blade REF 378607

    Recall: Z-0634-03 · Initiated January 24, 2003

    Recall

    Recall Number
    Z-0634-03
    Event Number
    25652
    Firm
    BD Opthalmic Systems
    Product Code
    HMY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 24, 2003
    Posted
    March 12, 2003
    Terminated
    April 28, 2003
    Address
    411 Waverly Oaks Road, Waltham, MA, 02452

    Description

    BD K-3000 Microkeratome Blade REF 378607

    Reason

    Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.

    Action

    BD Ophthalmic notified customers by telephone and email on 1/ 24/03. Users are requested to destroy blades and Certify destruction by returning reply form.

    Distribution

    Nationwide

    Quantity

    1539 Blades