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.
FDA Recall Z-2427-2018 · Posted None
Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeFTL
Date Initiated2018-03-15
Date Terminated2019-12-11
Product Quantity936
Reason for Recall
Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.