BEUDAMED
    FDA Recall Terminated

    Genzyme Biosurgery Essentials Kit, Item Number 82004

    Recall: Z-2310-2010 · Initiated July 13, 2010

    Recall

    Recall Number
    Z-2310-2010
    Event Number
    56218
    Firm
    Genzyme Corporation
    FEI Number
    3002836339
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 13, 2010
    Posted
    August 28, 2010
    Terminated
    January 30, 2012
    Address
    64 Sidney Street, Cambridge, MA, 02139

    Description

    Genzyme Biosurgery Essentials Kit, Item Number 82004

    Reason

    Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field.

    Action

    Genzyme notiifed physicians with the Dear Doctor letter on July 13, 2010 via UPS Ground delivery. The letter informed healthcare workers of the recent incidents and advise them to heed the Essentials Kit label and exercise proper handling of the Kit.. A fax return form will be provided for the physician to sign and return to Genzyme to acknowledge receipt of the notification. Contact Genzyme Medical Information at 800-453-6948, option #3 for any additional information or contact your Genzyme sales representative with any questions.

    Distribution

    Nationwide

    Quantity

    3132 kits