BEUDAMED
    FDA Recall Terminated

    Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for use in Magnetic Resonance environments; Distributed by Teleflex Medical, Research Triangle Park, NC 27709; catalog number 005852300

    Recall: Z-0758-2007 · Initiated March 1, 2007

    Recall

    Recall Number
    Z-0758-2007
    Event Number
    37591
    Firm
    Teleflex Medical
    FEI Number
    3004959265
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 1, 2007
    Posted
    May 2, 2007
    Terminated
    May 3, 2007
    Address
    2345 Waukegan Rd, Ste 120, Bannockburn, IL, 60015-1580

    Description

    Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for use in Magnetic Resonance environments; Distributed by Teleflex Medical, Research Triangle Park, NC 27709; catalog number 005852300

    Reason

    The MRI Battery is out of specification for its magnetic content.

    Action

    Teleflex telephoned the account on 3/1/07, and faxed them a follow-up recall letter on the same date. The account was informed that the batteries did not meet specification, and was requested to check the batteries in the laryngoscope kit shipped to them for the affected battery lot numbers, and return the affected batteries to Teleflex for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

    Distribution

    Georgia

    Quantity

    1 kit