BEUDAMED
    FDA Enforcement Class I Terminated

    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.

    Recall: Z-2212-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2212-2016
    Event ID
    74465
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    July 1, 2016
    Classification Date
    July 22, 2016
    Termination Date
    March 29, 2017
    Address
    75 N Fairway Dr, N/A, Vernon Hills, IL, 60061-1845, United States

    Description

    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.

    Reason

    BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs

    Code Info

    Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16

    Distribution

    Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.

    Quantity

    10