Date Initiated by Firm |
September 19, 2016 |
Create Date |
September 30, 2016 |
Recall Status1 |
Terminated 3 on December 13, 2016 |
Recall Number |
Z-2916-2016 |
Recall Event ID |
75048 |
Product Classification |
Powered laser surgical instrument - Product Code GEX
|
Product |
ReNew (a.k.a. Trio)
Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis |
Code Information |
Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01. |
Recalling Firm/ Manufacturer |
New Star Lasers, Inc. 9085 Foothills Blvd Roseville CA 95747-7130
|
For Additional Information Contact |
Nina Davis 916-677-1909
|
Manufacturer Reason for Recall |
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
|
FDA Determined Cause 2 |
Labeling False and Misleading |
Action |
Letters sent on September 19, 2016 via US mail advised customers of the unapproved claims that may be in their literature and advised of the approved uses for each device. |
Quantity in Commerce |
5 systems |
Distribution |
US distribution only. |
Total Product Life Cycle |
TPLC Device Report
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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.
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