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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Force TriVerse Electrosurgical Devices

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  Class 2 Device Recall Covidien Force TriVerse Electrosurgical Devices see related information
Date Initiated by Firm February 10, 2020
Date Posted February 25, 2020
Recall Status1 Terminated 3 on April 26, 2024
Recall Number Z-1446-2020
Recall Event ID 84991
510(K)Number K150735  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084
20884524000081; 10884524001937
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 
Recalling Firm/
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 2
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.
Quantity in Commerce 70361
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = COVIDIEN