LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Reported: November 24, 2021 Initiated: September 29, 2021 #Z-0260-2022
Product Description
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Reason for Recall
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.
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 75 Units
- 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
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220. Recalled by CooperSurgical, Inc.. Units affected: 75 Units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0260-2022.
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