FDA-Device2021-11-24Class II
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
CooperSurgical, Inc.
Hazard
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.
Sold states
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
Affected count
75 Units
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0260-2022Don't want to check this manually?
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