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

FDA Device Recall #Z-1447-2020 — Class II — February 10, 2020

Recall Summary

Recall Number Z-1447-2020
Classification Class II — Moderate risk
Date Initiated February 10, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Covidien Llc
Location Mansfield, MA
Product Type Devices
Quantity N/A

Product Description

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 Pattern

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.)

Lot / 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

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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