BEUDAMED
    FDA Recall Terminated

    Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; Teleflex Medical, Bannockburn, IL 60015; catalog number 004413300

    Recall: Z-1225-06 · Initiated June 15, 2006

    Recall

    Recall Number
    Z-1225-06
    Event Number
    35669
    Firm
    Teleflex Medical
    FEI Number
    3004959265
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    June 15, 2006
    Posted
    July 13, 2006
    Terminated
    August 28, 2009
    Address
    2345 Waukegan Rd, Ste 120, Bannockburn, IL, 60015-1580

    Description

    Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; Teleflex Medical, Bannockburn, IL 60015; catalog number 004413300

    Reason

    Teleflex Medical has identified that the product may malfunction, causing the handle to heat up. There is a potential for the heated handle to burn the user.

    Action

    Teleflex Medical sent Urgent Medical Device Recall letters dated 6/15/06 to the direct accounts, informing them of the potential for the handle to heat up, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

    Distribution

    Nationwide and Canada, Colombia, Costa Rica and Chile.

    Quantity

    1,408 laryngoscopes