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Recall Observatory FDA recall evidence

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.

Z-2427-2018

March 15, 2018

Class II

Product summary

Firm
Covidien LLC
Event
Event 79735
Status
Terminated
Classification
Class II
Quantity
936
Official record key
device-enforcement:Z-2427-2018

Official wording

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

Code information: Lot #s 72550127X 72770140X 72770141X 73000048X

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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