FDAClass IIJuly 18, 2018

LigaSure" Exact Dissector Nano Coated 20.6mm-21cm recall

LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures…

Why was LigaSure" Exact Dissector Nano Coated 20.6mm-21cm recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #s 72550127X 72770140X 72770141X 73000048X

Product
LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures…
Recalling firm
Covidien LLC
Quantity
936
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
Recall date
July 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls