Recall Z-1446-2020— Covidien Llc

Name: FDA recall Z-1446-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-10

Class II · Terminated

Class II FDA medical device recall by Covidien Llc, initiated 2020-02-10, terminated 2024-04-26. It names one FDA 510(k) clearance: K150735. Product: Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934. Reason: Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection..

Recalling firm: Covidien Llc
Classification: Class II
Status: Terminated
Initiated: 2020-02-10
Terminated: 2024-04-26
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K150735 — Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-footCovidien·cleared 2015-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.