Covidien LLC recalls LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use…

Recall date

March 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2427-2018

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

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

Why it was recalled

Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.