BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0260-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0260-2022
    Event ID
    88648
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 24, 2021
    Initiation Date
    September 29, 2021
    Classification Date
    November 18, 2021
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    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.

    Code Info

    Serial Numbers: 2018100001 2018100002 2018100003

    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