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U.S. Department of Health and Human Services

Class 2 Device Recall LEEP Precision Integrated System

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  Class 2 Device Recall LEEP Precision Integrated System see related information
Date Initiated by Firm April 23, 2019
Create Date June 19, 2019
Recall Status1 Terminated 3 on April 24, 2020
Recall Number Z-1840-2019
Recall Event ID 82821
510(K)Number K963348  
Product Classification Electrocautery, gynecologic (and accessories) - Product Code HGI
Product LEEP Precision Integrated System 120V, Model LP-10-120

Product Usage:
The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .
Code Information 2018110001,2018110002, 2018110003, 2018110004, 2018110005,2018110006, 2018110007, 2018110008,2018110011, 2018110012,2018110013, 2018110014, 2018110015,2018110016, 2018110017, 2018110019, 2018110020,2018110021,& 2018110022
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		 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
FDA Determined
Cause 2		 Process control
Action On April 23, 2019, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to immediately discontinue use of the discrepant product, quarantine the product, and replace the 2 main fuses with the 2 fuses provided with the firm's mailing. Customers were provided with instructions to replace the fuses. Once customers have successfully completed the fuse replacement, they are asked to complete the Acknowledgement and Receipt form and return it to CooperSurgical. If you have any questions, please contact the firm at 203-601-5200 ext. 3300.
Quantity in Commerce 19
Distribution US Nationwide Distribution in the states of CA, CT, IN, MA, MI, MN, NC, NV, NY, OH, TX, WA and WI.
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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