FDA recall Z-1447-2020

Product

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

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-1447-2020