BEUDAMED
    FDA Recall Terminated

    ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures

    Recall: Z-2396-2011 · Initiated April 7, 2011

    Recall

    Recall Number
    Z-2396-2011
    Event Number
    58518
    Firm
    Encision, Inc.
    FEI Number
    1000117361
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    April 7, 2011
    Posted
    May 31, 2011
    Terminated
    August 9, 2011
    Address
    6797 Winchester Cir, Boulder, CO, 80301-3513

    Description

    ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures

    Reason

    Sterility may be compromised due to holes in packaging.

    Action

    Encision, Inc. sent an Important Safety Notice letter dated April 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to either carefully inspect any remaining pouches for readily visible holes in the Tyvek pouch, or return the affected lots to Encision for inspection. Customers were also asked to fill in and fax back the attached Confirmation to 303-444-2693.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand

    Quantity

    952 Ten-Count Boxes