BEUDAMED
    FDA Recall Open, Classified

    A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

    Recall: Z-0310-2021 · Initiated September 17, 2020

    Recall

    Recall Number
    Z-0310-2021
    Event Number
    86412
    Firm
    Genicon, Inc.
    FEI Number
    3002590791
    Product Code
    FZP
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    September 17, 2020
    Address
    6869 Stapoint Ct, Ste 112, Winter Park, FL, 32792-6603

    Description

    A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

    Reason

    Device malfunction causing the applier to jam, and clip loading failures.

    Action

    On 9/17/20 the firm sent a notification to its consignees with the following instructions: Your assistance is appreciated and necessary to prevent any potential harm from the use of affected product. This recall is being carried out to the user level. If you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification. Please complete and also encourage your customers to complete and return the enclosed response form as soon as possible. Return the form by e-mail to [email protected]. In addition, if you or your customers have any of the affected devices listed in this letter, and the product is located within the United States of America, please contact Genicon (contact information listed below) to coordinate the return of the product associated with this action at no additional cost.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of FL, TN, MO, CA, GA, and IN. The countries of Chile, Croatia, Dubai (UAE), Equador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Iraq, Ireland, Israel, Jordan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Palestinian, Quatar, Saudi Arabia, Slovenia, South Africa, Switzerland, Tunisia, United Kingdom, and Venezuela.

    Quantity

    8,872 devices