BEUDAMED
    FDA Recall Terminated

    STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box is placed into a shipping container. The Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.

    Recall: Z-0068-2012 · Initiated March 5, 2008

    Recall

    Recall Number
    Z-0068-2012
    Event Number
    60000
    Firm
    Kapp Surgical Instrument Inc
    FEI Number
    1522875
    Product Code
    KGT
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    March 5, 2008
    Posted
    October 19, 2011
    Terminated
    February 19, 2013
    Address
    4919 Warrensville Center Rd, Warrensville Heights, OH, 44128-4353

    Description

    STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box is placed into a shipping container. The Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.

    Reason

    A portion of the labeled expiration date is missing. The expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration. However, the shelf box containing the pouches is labeled correctly.

    Action

    Surgical Concepts, Inc ( A subsidiary of Kapp Surgical Instrument Inc) sent a notification letter dated March 5, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm ceased distribution of the suspect product on December 5, 2007. The letter informs the firm's customers (both distributors and medical user/customers) of the expiration date labeling omission of the last digit of the year of expiration. It goes on to explain that the incomplete expiration date is present on the individual packages only and that the shelf boxes are labeled correctly with the complete/correct expiration date. The letter provides the customers with a contact person and a toll free telephone number 1-(800) 282-5277, to call in order to make arrangements for receive replacement labels for any misbranded packages received.

    Distribution

    Nationwide Distribution-- including the states of AK, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MT, NC, NM, OH, PA, TN, TX, UT, and VA

    Quantity

    59 boxes (3540 units)