BEUDAMED
    FDA Recall Terminated

    Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.

    Recall: Z-1143-2013 · Initiated February 14, 2013

    Recall

    Recall Number
    Z-1143-2013
    Event Number
    64538
    Firm
    Elana, Inc.
    FEI Number
    3006784599
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    February 14, 2013
    Posted
    April 18, 2013
    Terminated
    May 9, 2013
    Address
    10480 Little Patuxent Pkwy, Suite 400, Columbia, MD, 21044-3568

    Description

    Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.

    Reason

    Distribution of an unapproved device into interstate commerce.

    Action

    Elana Inc. issued an Urgent: Medical Device Recall letter on February 14, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the Elana Catheter Sizer 2.0 as soon as possible. The Sizer 2.0 was intended as an optional accessory to the Elana Surgical Kit. The Elana Surgical Kit may be used properly without the Elana Catheter Sizer 2.0. Please acknowledge receipt of these instructions immediately by Email: [email protected] or Fax: 301-215-7038. The return shipping address for the Sizer 2.0 is Elana, Inc., 10480 Little Patuxent Parkway, Suite 400, Columbia, MD 21044 USA. Contact information for questions: Phone: 301-215-7010 or 443-538-4923 or +1 31 30 2537276 www.elana.com.

    Distribution

    Distributed in the states of Pennsylvania, Texas, and New York.

    Quantity

    3 devices