BEUDAMED
    FDA Enforcement Class III Terminated

    LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.

    Recall: Z-1093-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1093-2013
    Event ID
    64776
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lighthouse For The Blind
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 17, 2013
    Initiation Date
    March 22, 2013
    Classification Date
    April 10, 2013
    Termination Date
    November 25, 2013
    Address
    10440 Trenton Ave, Olivette, MO, 63132-1223, United States

    Description

    LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.

    Reason

    The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels 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 sterili

    Code Info

    All kits shipped between 1/12010 through 3/4/2013.

    Distribution

    Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.

    Quantity

    425 kits