LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
- Company
- Coopersurgical, Inc.
- Recall Initiated
- September 29, 2021
- Recall Number
- Z-0260-2022
- Quantity
- 75 Units
- Firm Location
- Trumbull, CT
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.
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
Lot / Code Info
Serial Numbers: 2018100001 2018100002 2018100003
Root Cause
Component design/selection
Action Taken
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: recall@coopersurgical.com 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.