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Recall Observatory FDA recall evidence

Device 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.

Z-1213-2015

February 03, 2015

Class II

Product summary

Firm
Norwex Usa Inc
Event
Event 70456
Status
Terminated
Classification
Class II
Quantity
35,214
Official record key
device-enforcement:Z-1213-2015

Official wording

Reason: The toothbrush head can potentially disengage from the handle.

Code information: Model Number 354075, Light Blue; Model Number 354076, Green; Model Number 354077, Pink; Model Number 354078, Dark Blue

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The toothbrush head can potentially disengage from the handle.