BEUDAMED
    FDA Recall Terminated

    Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"

    Recall: Z-1808-2010 · Initiated May 13, 2010

    Recall

    Recall Number
    Z-1808-2010
    Event Number
    55724
    Firm
    Harris Medical Resources
    FEI Number
    3007232259
    Product Code
    MXG
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    May 13, 2010
    Posted
    June 16, 2010
    Terminated
    December 10, 2010
    Address
    3535 W Irving Park Rd, Chicago, IL, 60618-3219

    Description

    Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"

    Reason

    The Harris UV Lamp was promoted for sub-lingual treatment of HIV/AIDS; Hepatitis B; Hepatitis C; Malaria, Typhoid, Amoeba Infections and other blood diseases. The product was marketed without a 510(k), or an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). Questions are directed to the firm at 773-583-7500.

    Action

    Urgent Device Recall letters were sent registered, certified mail, return receipt requested, to the direct accounts on 5/13/10 - 5/18/10. The accounts were informed that Harris could make no claims as to the safety or efficacy of the Harris Medical UV Lamp in their possession and could recommend no medical indications for use because the necessary regulatory filings have not been completed and reviewed by the FDA, and that Harris Medical has no approved investigation clinical trials underway for the Harris Medical UV Lamp. The accounts were requested to check their inventory and quarantine any Harris Medical UV Lamps they may have in their possession and return them to Harris Medical using the enclosed pre-paid UPS shipping label. If the accounts further distributed the device, they were instructed to sub-recall them to the user level. The accounts were also requested to complete and return via mail or fax the enclosed return response form acknowledging the receipt and understanding of the recall letter and indicating the disposition of the devices. Any questions were directed to Thomas Perez at the company, at 773-583-7500.

    Distribution

    Florida, Hawaii, Ohio, Texas and internationally to Canada, Dominican Republic, Israel, Kenya and Peru

    Quantity

    20 units