BEUDAMED
    FDA Recall Terminated

    Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.

    Recall: Z-1496-2011 · Initiated February 2, 2011

    Recall

    Recall Number
    Z-1496-2011
    Event Number
    57884
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    KGX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 2, 2011
    Posted
    March 2, 2011
    Terminated
    November 7, 2012
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.

    Reason

    Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.

    Action

    Ethicon sent their recall letters with business reply cards attached on February 2, 2011 via UPS overnight mail. Customers are informed of the issue and asked to return the attached business reply card.

    Distribution

    Worldwide distribution, including USA, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Repub, Chile, China, Denmark, Dominican Repub, Egypt, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, ireland, Israel, italy, Japan, Korea, Lithuania, Luxembourg, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Palestine, Puerto Rico, Reunion, Russia, Senegal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Ukraine, and Venezuela.

    Quantity

    725,772