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
|