BEUDAMED
    FDA Enforcement Class II Terminated

    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant

    Recall: Z-2467-2012 · Reported October 3, 2012

    Enforcement

    Recall Number
    Z-2467-2012
    Event ID
    62948
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mc-NEIL-PPC, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2012
    Initiation Date
    July 2, 2012
    Classification Date
    September 27, 2012
    Termination Date
    September 27, 2013
    Address
    199 Grandview Rd, N/A, Skillman, NJ, 08558-1311, United States

    Description

    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant

    Reason

    Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that thi

    Code Info

    The following Lot Numbers were identified: 2721W; 2591W; 2321W; 1681W; 0921W; 0651W; 0471W; 0361W; 0221W; 0041W; 0110H; 0100H; 0090H; 0080H; 0030H; 0179H; 0159H; 0219H and 3489RT.

    Distribution

    Nationwide Distribution

    Quantity

    818,712