BEUDAMED
    FDA Recall Terminated

    Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.

    Recall: Z-0181-2010 · Initiated September 27, 2009

    Recall

    Recall Number
    Z-0181-2010
    Event Number
    53458
    Firm
    Organogenesis, Inc.
    FEI Number
    1000148471
    Product Code
    MGR
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 27, 2009
    Posted
    November 12, 2009
    Terminated
    March 31, 2010
    Address
    150 Dan Road, Canton, MA, 02021-2820

    Description

    Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.

    Reason

    Unit contaminated with Staphylococcus epidermidis

    Action

    Organogenesis, Inc. initiated a recall notification dated September 28, 2009 via fax to Physicians asking for return of unused affected product. If the unit was used, Physicians are advised to use standard wound care precautions to assure the safety of the patient. Users were asked to acknowledge receipt by completing and returning the notification to the firm. For further information, contact Organogenesis, Inc. at 1-888-432-5232.

    Distribution

    Nationwide Distribution

    Quantity

    60 units