Recall Z-2427-2018 ยท FTL Mesh, Surgical, Polymeric
Covidien LLC
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.
| Date | Mar 15, 2018 |
| Status | Terminated |
| Reason | Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices. |
| Root cause | Other |
| Action | 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 sh |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150091 | Versatex Monofilament Mesh Sofradim Production, May 26, 2015 |