BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1001-2013 · Initiated March 4, 2013

    Recall

    Recall Number
    Z-1001-2013
    Event Number
    64585
    FEI Number
    3004932373
    Product Code
    OJU
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    March 4, 2013
    Posted
    March 26, 2013
    Terminated
    May 12, 2014
    Address
    CareFusion 213, LLC 1550, Northwestern Drive El Paso, TX, 79912-8000

    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.

    Action

    CareFusion sent an Urgent Recall Notice dated March 4, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, quarantine and return the affected product for replacement. For questions call (913) 345-3504.

    Distribution

    USA Nationwide Distribution

    Quantity

    13,749,000