FDA-Device2020-03-11Class II
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
Covidien Llc
Hazard
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
Sold states
Nationwide domestic distribution. Foreign distribution to Australia, Canada, Austria Belgium Canary Islands Czech Republic Denmark Finland France Germany Greece Hungary Italy Jordan Kazakhstan Kenya Lithuania Luxembourg North Macedonia Poland Portugal Reunion Romania Russian Federation Serbia Slovakia Spain Sweden Switzerland United Kingdom No U.S. distribution of Kits. Foreign distribution in EMEA only. (Europe, Middle East and Africa.)
Affected count
70361
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1446-2020Don't want to check this manually?
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