BEUDAMED
    FDA Recall Terminated

    FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product. Indicated for patients who wold benefit from a suction device particularly as the device may promote wound healing.

    Recall: Z-1620-2008 · Initiated March 31, 2008

    Recall

    Recall Number
    Z-1620-2008
    Event Number
    47521
    Firm
    Smith And Nephew, Inc. Wound Management Division
    FEI Number
    3006760724
    Product Code
    BTA
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 31, 2008
    Posted
    August 6, 2008
    Terminated
    November 18, 2008
    Address
    11775 Starkey Road, Largo, FL, 33773-4727

    Description

    FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product. Indicated for patients who wold benefit from a suction device particularly as the device may promote wound healing.

    Reason

    Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.

    Action

    Consignees were notified of recall by letter (Correction and Removal Notification) sent to customers on 3/31/08. They were asked to check their stocks, identify, and return all affected units to Smith & Nephew according to the instructions. Consignees are to contact the Customer Care Center at 1-800-876-1261, if they have additional questions.

    Distribution

    Nationwide Distribution.

    Quantity

    4796