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U.S. Department of Health and Human Services

Class 2 Device Recall LEEP Precision Integrated System for electrosurgical excision procedures.

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  Class 2 Device Recall LEEP Precision Integrated System for electrosurgical excision procedures. see related information
Date Initiated by Firm June 18, 2019
Create Date July 23, 2019
Recall Status1 Terminated 3 on June 15, 2020
Recall Number Z-2057-2019
Recall Event ID 83100
510(K)Number K963348  K963653  
Product Classification Electrocautery, gynecologic (and accessories) - Product Code HGI
Product LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
Code Information Lot/Serial Numbers: 1214007 2016050014 2016060026 2016080009 2016100021 2017010021 2017050015 2017080013 2015080015 2016050015 2016060027 2016080010 2016100023 2017010023 2017050016 2017080014 2015110007 2016050016 2016060028 2016080011 2016100024 2017010024 2017050017 2017080015 2015110019 2016050017 2016060029 2016080012 2016100025 2017020001 2017060001 2017090001 2016030001 2016050018 2016060030 2016080013 2016100026 2017020002 2017060002 2017090003 2016030002 2016050019 2016060031 2016080014 2016100027 2017020003 2017060003 2017090004 2016030003 2016050020 2016070001 2016080015 2016100028 2017020005 2017060004 2017090005 2016030004 2016050021 2016070002 2016080016 2016100029 2017020006 2017060005 2017090006 2016030005 2016050022 2016070003 2016080017 2016100030 2017020007 2017060006 2017090007 2016030006 2016050023 2016070004 2016080018 2016100031 2017020008 2017060007 2017090008 2016030007 2016050024 2016070005 2016080019 2016100032 2017020009 2017060008 2017090009 2016030008 2016050025 2016070006 2016080020 2016100033 2017020010 2017060009 2017090010 2016030009 2016050027 2016070007 2016080021 2016100034 2017020011 2017060010 2017090011 2016030010 2016050028 2016070008 2016080022 2016100035 2017020012 2017060011 2017090012 2016030011 2016050029 2016070009 2016080023 2016120001 2017020013 2017060012 2017090014 2016030012 2016050030 2016070010 2016080024 2016120002 2017020014 2017060013 2017110002 2016030013 2016050031 2016070011 2016080025 2016120003 2017020015 2017060014 2017110003 2016030014 2016050032 2016070012 2016080026 2016120004 2017020017 2017060015 2017110004 2016030015 2016050033 2016070013 2016080027 2016120005 2017020018 2017070001 2017110005 2016030016 2016050034 2016070014 2016080029 2016120006 2017020019 2017070002 2017110006 2016030017 2016060001 2016070015 2016080030 2016120007 2017020020 2017070003 2017110007 2016040001 2016060002 2016070016 2016080031 2016120008 2017040001 2017070004 2017110008 2016040002 2016060003 2016070017 2016080032 2016120009 2017040002 2017070005 2017110010 2016040003 2016060004 2016070018 2016080033 2016120010 2017040003 2017070006 2017110011 2016040004 2016060005 2016070019 2016080034 2016120011 2017040005 2017070007 2017110012 2016040005 2016060006 2016070020 2016080035 2017010001 2017040006 2017070008 2017110013 2016040006 2016060007 2016070021 2016080036 2017010002 2017040007 2017070009 2017110014 2016040007 2016060008 2016070022 2016100001 2017010003 2017040008 2017070010 2017110015 2016040008 2016060009 2016070023 2016100002 2017010004 2017040009 2017070011 2017110016 2016040009 2016060010 2016070024 2016100003 2017010005 2017040010 2017070012 2017110017 2016040010 2016060011 2016070025 2016100004 2017010006 2017040011 2017070013 2017110018 2016040011 2016060012 2016070026 2016100005 2017010007 2017040013 2017070014 2017110019 2016050001 2016060013 2016070027 2016100006 2017010008 2017040014 2017070015 2017110020 2016050002 2016060014 2016070028 2016100007 2017010009 2017050001 2017080001 2017110021 2016050003 2016060015 2016070029 2016100008 2017010010 2017050003 2017080002 2017110022 2016050004 2016060016 2016070030 2016100009 2017010011 2017050005 2017080003 2017110023 2016050005 2016060017 2016070031 2016100010 2017010012 2017050006 2017080004 2017110024 2016050006 2016060018 2016080001 2016100011 2017010013 2017050007 2017080005 2017110025 2016050007 2016060019 2016080002 2016100012 2017010014 2017050008 2017080006 2017110026 2016050008 2016060020 2016080003 2016100013 2017010015 2017050009 2017080007 2017110027 2016050009 2016060021 2016080004 2016100014 2017010016 2017050010 2017080008 2017110028 2016050010 2016060022 2016080005 2016100016 2017010017 2017050011 2017080009 2017110029 2016050011 2016060023 2016080006 2016100017 2017010018 2017050012 2017080010 2017110030 2016050012 2016060024 2016080007 2016100018 2017010019 2017050013 2017080011  2016050013 2016060025 2016080008 2016100019 2017010020 2017050014 2017080012
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		 The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.
FDA Determined
Cause 2		 Device Design
Action The firm notified customers of the recall via Urgent Medical Device Recall letters dated June 18, 2019. Customers were informed that the device may fail to cut, coagulate, or blend tissue with use of the Foot Pedal. Serious injuries could occur due to this failure mode. Customers were instructed to do the following: - Use the Hand-Switch Pencil and Cord (Part Numbers: 395310/LP50101) to activate the cut, coagulation, or blend functions by hand control instead of foot action using the Foot Pedal. - Complete the acknowledgement and receipt form and return to the firm. If you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email recall@coopersurgical.com.
Quantity in Commerce 358
Distribution Nationwide domestic distribution. International distribution to Canada and Costa Rica.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HGI and Original Applicant = WALLACH SURGICAL DEVICES, INC.
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