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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Force TriVerse electrosurgical device

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  Class 2 Device Recall Covidien Force TriVerse electrosurgical device see related information
Date Initiated by Firm February 15, 2019
Create Date March 18, 2019
Recall Status1 Terminated 3 on June 17, 2020
Recall Number Z-1020-2019
Recall Event ID 82244
510(K)Number K150735  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue.

Product Usage:
Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes.

Item Code: FT3000F
Code Information Lot Number: 80390309X  UDI-Device Identifier (GTIN/UPN) 10884524000084/ 20884524000081
Recalling Firm/
Manufacturer		 Covidien, PLC
5920 Longbow Dr
Boulder CO 80301-3202
For Additional Information Contact SAME
303-530-6247
Manufacturer Reason
for Recall		 Potential for the sterile packaging to be compromised
FDA Determined
Cause 2		 Equipment maintenance
Action Medtronic notified via letter by Federal Express and/or certified mail on February 15, 2019. The letter informs customers of the recall of one production lot of Covidien Force TriVerse" electrosurgical devices 10 cord due to the potential for the sterile packaging to be compromised and the actions they should take. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item code and lot. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Force TriVerse" electrosurgical devices 10 cord. " Complete the Recalled Product Return Form
Quantity in Commerce 850 units
Distribution US Nationwide Distribution
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
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