BEUDAMED
    FDA Recall Terminated

    LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.

    Recall: Z-1091-2013 · Initiated March 22, 2013

    Recall

    Recall Number
    Z-1091-2013
    Event Number
    64776
    Firm
    Lighthouse For The Blind
    FEI Number
    1000118065
    Product Code
    LRR
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    March 22, 2013
    Posted
    April 10, 2013
    Terminated
    November 25, 2013
    Address
    10440 Trenton Ave, Olivette, MO, 63132-1223

    Description

    LHB, Perishable Item Pack Type III. Kit number: 2114011-100. 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

    Action

    The firm sent "URGENT DEVICE RECALL" letters dated March 22, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-542-3697 for questions regarding this notice.

    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

    227 kits