Events

Recall of Device Recall SilverCare Junior Toothbrush

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Norwex Usa Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70456
  • Event Risk Class
    Class 2
  • Event Number
    Z-1213-2015
  • Event Initiated Date
    2015-02-03
  • Event Date Posted
    2015-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133827
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Toothbrush, manual - Product Code EFW
  • Reason
    The toothbrush head can potentially disengage from the handle.
  • 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.

Device

Device Recall SilverCare Junior Toothbrush
  • Model / Serial
    Model Number 354075, Light Blue; Model Number 354076, Green; Model Number 354077, Pink; Model Number 354078, Dark Blue
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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.
  • Manufacturer
    Norwex Usa Inc

Manufacturer

Norwex Usa Inc
  • Manufacturer Address
    Norwex Usa Inc, 14679 Midway Rd Ste 115, Addison TX 75001-3193
  • Manufacturer Parent Company (2017)
    Norwex Usa Inc.
  • Source
    USFDA