Medical device recalls Moderate risk

Covidien Llc recalls Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa)…

Recall date
February 10, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1447-2020
FDA classification
Class II
Brand / firm
Covidien Llc
Sold / distributed
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 Slova…

Why it was recalled

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

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

What was recalled

Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT02 LAR28PLN MGBGLOCX1 SGGLOCX1 HEMICX1 LAPWL STOM25PL TGGLOCX1 TIROIDEKIT UROCYSPL VAGHCJ VATSZD2 VGYN VMED VMED3 ZGVATS1

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