FDA recall Z-1446-2020

Covidien Llc · Class II · device

Product

Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934

Reason for recall

Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.

Distribution

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.)

Key facts

Status: Terminated
Initiation date: 2020-02-10
Report date: 2020-03-11
Termination date: 2024-04-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1446-2020