BEUDAMED
    FDA Recall Open, Classified

    etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

    Recall: Z-1461-2022 · Initiated June 21, 2022

    Recall

    Recall Number
    Z-1461-2022
    Event Number
    90523
    Firm
    Touch US Llc
    FEI Number
    3023066634
    Product Code
    NBW
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    June 21, 2022
    Address
    94 Lilac Ln, Paramus, NJ, 07652-5291

    Description

    etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

    Reason

    Device was marketed without FDA 510(k) clearance or a PMA.

    Action

    On June 21, 2022, the firm communicated the recall to customers who purchased the product through the company's website. The firm is also making an effort to recall the product that was sold through Amazon Marketplace. Customers should return any affected product to eTouch US LLC. The firm will provide a full refund of the original purchase cost to the customer when the recalled device is received from the customer. If you have any questions, please contact the firm Monday thru Friday, 9AM - 5PM Eastern Time: Support Team: 888-670-9070 Email: [email protected]

    Distribution

    US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA

    Quantity

    149