BEUDAMED
    FDA Recall Terminated

    MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit containing a skin staple remover, a PVP prep pad and a 3 x 3 gauze sponge; 50 kits per case; Made for Owens & Minor

    Recall: Z-1137-04 · Initiated July 12, 2004

    Recall

    Recall Number
    Z-1137-04
    Event Number
    29579
    Firm
    Medikmark, Incorporated
    FEI Number
    1450943
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 12, 2004
    Posted
    July 22, 2004
    Terminated
    June 27, 2006
    Address
    3600 Burwood Dr, Waukegan, IL, 60085-8399

    Description

    MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit containing a skin staple remover, a PVP prep pad and a 3 x 3 gauze sponge; 50 kits per case; Made for Owens & Minor

    Reason

    The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.

    Action

    Recall notifications were sent by fax and follow-up registered mail to the direct account distributors and users on 7/12-15/04. The accounts were informed of the potential non-sterility of the product and were instructed to immediately discontinue sale/use of the products and place all inventory in quarantine pending return to Medikmark. Distributors were instructed to sub-recall the kits from their customers. Any questions were directed to 1-847-596-7723.

    Distribution

    Nationwide

    Quantity

    70,750 kits