BEUDAMED
    FDA Enforcement Class III Terminated

    Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product

    Recall: Z-1001-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-1001-2013
    Event ID
    64585
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 213, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    March 4, 2013
    Classification Date
    March 26, 2013
    Termination Date
    May 12, 2014
    Address
    1550 Northwestern Drive, El Paso, TX, 79912-8000, United States

    Description

    Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product

    Reason

    An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized.

    Code Info

    Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353.

    Distribution

    USA Nationwide Distribution

    Quantity

    13,749,000