BEUDAMED
    FDA Recall Terminated

    Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.

    Recall: Z-0459-2009 · Initiated April 27, 2007

    Recall

    Recall Number
    Z-0459-2009
    Event Number
    50092
    Firm
    Sun Med, Inc.
    FEI Number
    1314417
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 27, 2007
    Posted
    December 24, 2008
    Terminated
    July 6, 2010
    Address
    12393 Belcher Road, Suite 450, Largo, FL, 33773-3097

    Description

    Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.

    Reason

    A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the MD Laryngoscope Blade GreenLine D Mac 3 has been detected. If breakage occurs during use, there is the potential for leaving approximately a one inch piece of acrylic tube in the patient's mouth.

    Action

    SunMed sent initial recall letter on April 27, 2007 to all distributors requesting that kits containing the MacIntosh size 3, consisting of lots number Gj and Ha be returned to facility. Replacement information was included in letter. On December 12, 2008, the firm issued a Device Recall Press Release with additional information on the potential for the tube to break during use leaving an approximate 1 inch piece of the acrylic tube in the patients mouth and subsequently requiring medical or surgical intervention to prevent serous injury to the patient. SunMed has notified its distributors and customers by certified mail and has arranged for return and replacement of all recalled products. Consumers with question may contact their distributor of the GreenLine/D or SunMed at 1-800-433-2797.

    Distribution

    Nationwide Distribution

    Quantity

    2,682 boxes (20 per box)