FDA-Device2018-07-18Class II
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.
Covidien LLC
Hazard
Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
Sold states
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
Affected count
936
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2427-2018Don't want to check this manually?
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