|
Class 2 Device Recall Covidien Clearify Visualization System |
|
Date Initiated by Firm |
October 04, 2016 |
Create Date |
December 22, 2016 |
Recall Status1 |
Terminated 3 on August 08, 2018 |
Recall Number |
Z-0889-2017 |
Recall Event ID |
75301 |
510(K)Number |
K062779
|
Product Classification |
Instrument, special lens, for endoscope - Product Code FEI
|
Product |
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens |
Code Information |
Lots beginning with: P4J, P4K, P4L, P4M, P5A, P5B, P5C, P5D, P5E, P5F, P5G, P5H, P5J, P5K, P5L, P5M, P6A, P6B, P6C, P6D and lots P6E0016GX,P6E0049GX
P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, P6E0212GX |
Recalling Firm/ Manufacturer |
Medtronic 60 Middletown Ave North Haven CT 06473-3908
|
Manufacturer Reason for Recall |
Product sterility is compromised due to breach of the sterile barrier
|
FDA Determined Cause 2 |
Employee error |
Action |
Covidien issued an Urgent Medical Device Recall letter on October 4, 2016 and a corrected letter on October 10, 2016 to US Customers via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices will be reworked.
Questions or concerns, contact your Medtronic representative or customer service at 800-882-5878. |
Quantity in Commerce |
1,293,169 systems |
Distribution |
Worldwide Distribution - US (Nationwide)
Foreign:
Austria
Belgium
Bulgaria
Brazil
Chile
Cyprus
Denmark
Egypt
Finland
France
France
Germany
Greece
Hungary
Iran
Ireland
Israel
Italy
Japan
Kenya
Kuwait
Latvia
Luxembourg
Mexico
Namibia
Netherlands
Nigeria
Norway
Poland
Portugal
Romania
Saudi Arabia
Serbia
Slovakia
South Africa
Spain
Sweden
Switzerland
Turkey
United Arab Emirates
United Kingdom |
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 = FEI and Original Applicant = NEW WAVE SURGICAL CORPORATION
|
|
|
|