Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1213-2015Class II

Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended...

Norwex USA Inc. / initiated 2015-02-03 / Terminated

Norwex Usa Inc began a recall of 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... on . FDA classified it as Class II and gives the reason as "The toothbrush head can potentially disengage from the handle". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1213-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Norwex USA Inc.
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.
Product code
EFW Toothbrush, Manual
Reason for recall
The toothbrush head can potentially disengage from the handle.
FDA root cause
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
Product codes and lots
Model Number 354075, Light Blue; Model Number 354076, Green; Model Number 354077, Pink; Model Number 354078, Dark Blue

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1213-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1213-2015Class IITerminatedVoluntary: Firm initiated