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U.S. Department of Health and Human Services

Class 2 Device Recall SilverCare Junior Toothbrush

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 Class 2 Device Recall SilverCare Junior Toothbrushsee related information
Date Initiated by FirmFebruary 03, 2015
Date PostedFebruary 26, 2015
Recall Status1 Terminated 3 on June 27, 2016
Recall NumberZ-1213-2015
Recall Event ID 70456
510(K)NumberK102871 
Product Classification Toothbrush, manual - Product Code EFW
ProductManual 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
FEI Number 3009289274
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
ActionNorwex 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 Commerce35,214
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = EFW
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