BEUDAMED
    FDA Recall Terminated

    Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute

    Recall: Z-1747-2011 · Initiated February 21, 2011

    Recall

    Recall Number
    Z-1747-2011
    Event Number
    58138
    Firm
    Organogenesis, Inc.
    FEI Number
    1000148471
    Product Code
    MGR
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 21, 2011
    Posted
    March 23, 2011
    Terminated
    July 28, 2011
    Address
    150 Dan Road, Canton, MA, 02021-2820

    Description

    Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute

    Reason

    Product sterility may be compromised

    Action

    Organogenesis contacted the accounts by telephone and fax on 2/24/11 to advise of the contamination and identification fo the organism for appropriate patient follow-up.

    Distribution

    Nationwide.

    Quantity

    7 units