FDA recall Z-2427-2018

Covidien LLC · Class II · device

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.

Reason for recall

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

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

Key facts

Status
Terminated
Initiation date
2018-03-15
Report date
2018-07-18
Termination date
2019-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2427-2018