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U.S. Department of Health and Human Services

Class 2 Device Recall LEEP PRECISION Generator 120V

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  Class 2 Device Recall LEEP PRECISION Generator 120V see related information
Date Initiated by Firm September 29, 2021
Create Date November 18, 2021
Recall Status1 Open3, Classified
Recall Number Z-0259-2022
Recall Event ID 88648
510(K)Number K963653  
Product Classification Electrocautery, gynecologic (and accessories) - Product Code HGI
Product LEEP PRECISION Generator 120V
Cooper Surgical Part Number: LP-20-120
Code Information Serial Numbers:  0215002 1214007 2015050001  2016060030 2016060031 2016070002 2016070004 2016070012 2016070017 2016070021 2016070022 2016070026 2016070027 2016070028 2016070030 2016070031 2016080002 2016080004 2016080007 2016080009 2016080015 2016080016 2016080017 2016080018 2016080019 2016080020 2016080021 2016080022 2016080025 2016080026 2016080027 2016080029 2016080031 2016080033 2016080034 2016080035 2016080036 2016100002 2016100004 2016100009 2016100010 2016100012 2016100013 2016100014 2016100016 2016100017 2016100018 2016100021 2016100023 2016100024 2016100025 2016100027 2016100028  2015050016 2015050017 2015050018 2015050019 2015050020 2015110007 2016030001 2016030002 2016030006 2016030007 2016030013 2016030015 2016040001 2016040002 2016040004 2016040006 2016040007 2016040010 2016050004 2016050006 2016050007 2016050010 2016050012 2016050013 2016050015 2016050016 2016050019 2016050029 2016050031 2016050034 2016060001 2016060002 2016060003 2016060004 2016060006 2016060007 2016060009 2016060012 2016060013 2016060016 2016060021 2016060022 2016060023 2016060025 2016060026 2016060028 2016060029 2016100029 2016100033 2016100034 2016100035 2016120002 2016120003 2016120004 2016120005 2016120008 2016120010 2016120011 2017010001 2017010002 2017010003 2017010004 2017010005 2017010006 2017010007 2017010009 2017010010 2017010011 2017010012 2017010015 2017010016 2017010018 2017010020 2017010023 2017020001 2017020002 2017020003 2017020004 2017020005 2017020006 2017020008 2017020011 2017020012 2017020013 2017020014 2017020017 2017020019 2017040001 2017040002 2017040003 2017040005 2017040008 2017040015 2017050008 2017050012 2017050013 2017050014 2017050015 2017050016 2017050017 2017060003 2017060004 2017060006 2017060010 2017060011 2017060012 2017060013 2017060014 2017060015 2017070002 2017070003 2017070005 2017070006 2017070009 2017070010 2017070012 2017070013 2017070015 2017080001 2017080003 2017080004 2017080005 2017080007 2017080010 2017080011 2017080015 2017090001 2017090003 2017090006 2017090009 2017090010 2017090014 2017110010 2017110012 2017110013 2017110015 2017110016 2017110017 2017110019 2017110026 2017110027 2017110028 2018100043 2019080030 2019080051 2019080052 2019100001  2019100002 2019100003 2019100017 2019100018 2019100019 2019100020 2020030021 2020040001 2020040002 2020040003 2020040004 2020070021 2020070022 2020070023 2020070024 2020070025 2020120001 2021010002 2021010003 2021010004 2021030041 2021030042 2021030043 2021030044 2021030045 2021040021 2021040022  
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action 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.
Quantity in Commerce 244 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HGI and Original Applicant = WALLACH SURGICAL DEVICES, INC.
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