Medical device recalls Moderate risk

Covidien, PLC recalls Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissu…

Recall date
February 15, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1020-2019
FDA classification
Class II
Brand / firm
Covidien, PLC
Sold / distributed
US Nationwide Distribution

Why it was recalled

Potential for the sterile packaging to be compromised

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F

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