Z-1447-2020Class II

Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East...

Name: Z-1447-2020 Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East...
Creator: Covidien Llc
Published: 2020-02-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-02-10 / Terminated / root cause: manufacturing process

FDA source

Covidien Llc began a recall of Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are... on 2020-02-10. FDA classified it as Class II and gives the reason as "Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1447-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-10
Posted: 2020-02-25
Terminated: 2024-04-26
Recalling firm: Medtronic, Inc.
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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 10, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the packaging issue and instructed to do the following: 1. Please immediately quarantine and discontinue use of the affected item codes and lots listed in the notice. 2. Please return affected product as indicated in the notice. All unused products from the affected item codes and lots must be returned. 3. If you have distributed Covidien Force TriVerse electrosurgical devices listed on Attachment A, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
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.)
Product codes and lots: Lots 0218917589 0218909457 0218940986 0219010003 0218954164 0218909455 0218938181 0219010001 0219015316 0218909452 0218953902 0219010002 0218862144 0218909456 0218953120 0219010000 0218909458 0218909460 0218917904 0219010004 0218909454 0218917602 0218962165 0219010005 0218909453 0218917603 0219013846 0219009999 0218909459 0218917588 0219013847 0218907363 0218953822 0218908405 0218953514 0218813863 0218782098 0218836471 0218836472 0218836473 0218836474 0218836470 0218863976 0218836468 0218836475 0218851370 0218836469 0218879245 0218836478 0218861244 0218927160 0218926415 0218907609

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1447-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1446-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-05
Z-1447-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-05

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)