BEUDAMED
    FDA Recall Terminated

    BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)

    Recall: Z-0066-2008 · Initiated August 9, 2007

    Recall

    Recall Number
    Z-0066-2008
    Event Number
    38739
    Firm
    Becton Dickinson and Company
    FEI Number
    1211998
    Product Code
    HMY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 9, 2007
    Posted
    October 23, 2007
    Terminated
    February 29, 2012
    Address
    411 Waverley Oaks Rd, Ste 2229, Waltham, MA, 02452-8448

    Description

    BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)

    Reason

    Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea

    Action

    BD Medical notified customers by Advisory Letter dated 8/09/07, advising users to return heads and bearing cartridges for replacement of the o-ring.

    Distribution

    Worldwide

    Quantity

    256 units