BEUDAMED
    FDA Recall Open, Classified

    LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220

    Recall: Z-0260-2022 · Initiated September 29, 2021

    Recall

    Recall Number
    Z-0260-2022
    Event Number
    88648
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HGI
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    September 29, 2021
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220

    Reason

    Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

    Action

    CooperSurgical issued Urgent Medical Device Recall to consignees via certified mail with confirmed delivery receipt dated 9/29/21. Letter states reason for recall, health risk and action to take: This Recall affects 2955 units manufactured since product launch in December 2009 and a corrective action has been initiated to prevent future recurrence. Please discontinue use of this product, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for repair of your device at CooperSurgical s expense, including shipping, and return of the product to you. Please feel free to reach us at 203-601-5200 ext. 3300. Please complete this form and return it via email: [email protected] or fax to 203.601.9870 ATTN: Product Surveillance. CooperSurgical will arrange for a product repair after this form has been received. Firm issued additional letter for the product LP-10-220 as it was not included in the initial recall letter. The letter dated 10/18/21 distributed to international accounts only.

    Distribution

    US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM

    Quantity

    75 Units