Z-2427-2018 Class II Terminated

Recalled by Covidien LLC — North Haven, CT

Recall Details

Product Type
Devices
Report Date
July 18, 2018
Initiation Date
March 15, 2018
Termination Date
December 11, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
936

Product Description

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 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

Code Information

Lot #s 72550127X 72770140X 72770141X 73000048X