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U.S. Department of Health and Human Services

Class 2 Device Recall LigaSure" Exact Dissector Nano Coated

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  Class 2 Device Recall LigaSure" Exact Dissector Nano Coated see related information
Date Initiated by Firm March 15, 2018
Create Date July 12, 2018
Recall Status1 Terminated 3 on December 11, 2019
Recall Number Z-2427-2018
Recall Event ID 79735
510(K)Number K150091  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product LigaSure" Exact Dissector Nano Coated 20.6mm-21cm

Product Usage:
A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
Code Information Lot #s 72550127X 72770140X 72770141X 73000048X
Recalling Firm/
Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact J. Bryan Dannettell
Manufacturer Reason
for Recall
Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
FDA Determined
Cause 2
Action Medtronic Regional sent a notification letter to customers via overnight delivery. the letter identified the affected product, problem and actions to be taken. The letter request that you quarantine and return any unused products of the affected item codes and production lots. Unused products from the affected item codes should be returned. If you have distributed Covidien LigaSure" Exact Dissector listed, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes must be returned. The potentially affected product was shipped to your facility between November 2017 and February 2018.
Quantity in Commerce 936
Distribution Worldwide Distribution in the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Swede, Switzerland and United Kingdom
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 = FTL and Original Applicant = SOFRADIM PRODUCTION