Recalls / —

—#179848

Product

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

FDA product code

GEI — Electrosurgical, Cutting & Coagulation & Accessories

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K150735

Affected lot / code info

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

Why it was recalled

Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Covidien Llc

Address

15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

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.)

Timeline

Recall initiated

2020-02-10

Posted by FDA

2020-02-25

Terminated

2024-04-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #179848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.