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Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 1088452...

FDA Device Recall #Z-1446-2020 — Class II — February 10, 2020

Recall Summary

Recall Number Z-1446-2020
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 70361

Product Description

Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934

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 181170378R 181170379R 181170380R 192100010R 192170108R 192170109R 192240106R 192240107R 192240108R 192630089R 192100011R 192660102R 192450230R 192660103R 192800040R 190530412R 190530413R 190600130R 190630011R 190640010R 190880338R 190880339R 190880340R 190880341R 191020334R 191160340R 191160342R 191300316R 191300317R 191370322R 191370323R 191510192R 191440287R 191510193R 191580245R 191580246R 191580247R 191650218R 191650219R 191720261R 191790222R 191790223R 191790224R 191860195R 191860197R 191090309R 191090310R 191440286R 191930105R 191930107R 191930108R 192170106R 192170107R 191720259R 192000197R 192000200R 192070039R 192100007R 192070038R 191160341R 191650217R 191860198R 191930106R 192000198R 192000199R 192520130R 192660097R 192660099R 192660100R 192070041R 192520129R 192380040R 192450224R 192450225R 192450227R 192520131R 192380041R 192600113R 192730131R 192870153R

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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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