Class 2 Device Recall Covidien Force TriVerse Electrosurgical Devices

• Date Initiated by Firm: February 10, 2020
• Date Posted: February 25, 2020
• Recall Status: Terminated on April 26, 2024
• Recall Number: Z-1447-2020
• Recall Event ID: 84991
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Covidien Llc; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Customer Service; 800-9629888 Ext. 2
• Manufacturer Reason for Recall: Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
• FDA Determined 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.)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.