BEUDAMED
    FDA Recall Terminated

    Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112. Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management.

    Recall: Z-1024-2011 · Initiated December 20, 2010

    Recall

    Recall Number
    Z-1024-2011
    Event Number
    57464
    Firm
    Vital Signs Colorado Inc.
    FEI Number
    1718887
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 20, 2010
    Posted
    February 2, 2011
    Terminated
    July 1, 2011
    Address
    11039 East Lansing Circle, Englewood, CO, 80112-5909

    Description

    Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112. Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management.

    Reason

    Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.

    Action

    Healthcare Systems sent an URGENT MEDICAL DEVICE CORRECTION letter dated December 20, 2010, to all affected consignees advising them of the possible problem and giving them interim safety instructions until new battery cartridges were available. Customers were instructed to complete and return the Confirmation Form which was included with the letter. For information regarding this recall call 973-956-5300.

    Distribution

    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, MA, MN, MO, NH, NJ, NY, OH, OK, SC, TN, TX, WA, and WV and the countries of Australia, Belgium, Canada, Dominican Republic, Ecuador, Germany, Hong Kong, Latvia, New Zealand, Taiwan, Turkey, and the UK

    Quantity

    2202 units