—#163231

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.

FDA product code: FTL — Mesh, Surgical, Polymeric
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K150091
Affected lot / code info: Lot #s 72550127X 72770140X 72770141X 73000048X

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

Medtronic Regional sent a notification letter to customers via overnight delivery. the letter identified the affected product, problem and actions to be taken. The letter request that you quarantine and return any unused products of the affected item codes and production lots. Unused products from the affected item codes should be returned. If you have distributed Covidien LigaSure" Exact Dissector listed, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes must be returned. The potentially affected product was shipped to your facility between November 2017 and February 2018.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

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

Timeline

Recall initiated: 2018-03-15
Terminated: 2019-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.