BEUDAMED
    FDA Recall Terminated

    AEM Disposable Electrode, J-Hook, 45cm, REF ES0310-45, Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

    Recall: Z-1543-2010 · Initiated April 5, 2010

    Recall

    Recall Number
    Z-1543-2010
    Event Number
    55286
    Firm
    Encision, Inc.
    FEI Number
    1000117361
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 5, 2010
    Posted
    May 6, 2010
    Terminated
    May 21, 2010
    Address
    6797 Winchester Cir, Boulder, CO, 80301-3513

    Description

    AEM Disposable Electrode, J-Hook, 45cm, REF ES0310-45, Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

    Reason

    Electrosurgical electrode tip insulation may crack and break off during use.

    Action

    A "Confirmation of Product Recall" letter dated April 5, 2010, was faxed by the firm (Encision, Inc.) to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to either return or destroy the affected electrodes and to contact any customers or sales representatives to whom they distributed the product and confirm they have been removed from use and/or they will pick them up for return. The customers is to complete form and fax to the attention of RA/QA at 1-303-444-2693 or return with the items. The number to call to arrange return and/or if you have any questions is 1-800-998-0986.

    Distribution

    Worldwide distribution: USA including states of CA, CT, IA, IN, KS, KY, MI, OK, TX, WV, and countries of New Zealand and The Netherlands.

    Quantity

    40 units