Date Initiated by Firm |
February 03, 2015 |
Date Posted |
February 26, 2015 |
Recall Status1 |
Terminated 3 on June 27, 2016 |
Recall Number |
Z-1213-2015 |
Recall Event ID |
70456 |
510(K)Number |
K102871
|
Product Classification |
Toothbrush, manual - Product Code EFW
|
Product |
Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use as a toothbrush. The silver plating is an antimicrobial agent which maintains the cleanliness of the brush by preventing growth of bacteria on and between the filaments after use. |
Code Information |
Model Number 354075, Light Blue; Model Number 354076, Green; Model Number 354077, Pink; Model Number 354078, Dark Blue |
Recalling Firm/ Manufacturer |
Norwex Usa Inc 14679 Midway Rd Ste 115 Addison TX 75001-3193
|
For Additional Information Contact |
204-647-0798
|
Manufacturer Reason for Recall |
The toothbrush head can potentially disengage from the handle.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Norwex sent an Urgent Product Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to call 1-866-450-7499. For questions regarding this recall call 204-647-0798. |
Quantity in Commerce |
35,214 |
Distribution |
Nationwide Distribution |
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.
|
510(K) Database |
510(K)s with Product Code = EFW and Original Applicant = PIAVE SPAZZOLIFICIO S.P.A.
|