BEUDAMED
    FDA Recall Terminated

    Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.

    Recall: Z-0138-2015 · Initiated September 8, 2014

    Recall

    Recall Number
    Z-0138-2015
    Event Number
    69279
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    NAD
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 8, 2014
    Posted
    October 24, 2014
    Terminated
    January 21, 2015
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3431

    Description

    Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.

    Reason

    Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.

    Action

    Coloplast sent an "Urgent Voluntary Recall Notification" dated September 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If they have further distributed the product they need to contact their customers immediately. For questions they can contact Coloplast Customer Care Representative at 800-533-0464. A second follow up "Urgent Voluntary Recall Notification" letter dated September 23, 2014 was also sent to consignees.

    Distribution

    US Distribution to MO and RI.

    Quantity

    6