LEEP PRECISION Generator 220V Cooper Surgical recall
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Why was LEEP PRECISION Generator 220V Cooper Surgical 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 2018100001 2018100002 2018100003
- Product
- LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 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
- Recall date
- November 24, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)