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Medical Device Recall - Warning Label Addition/Silver Care Toothbrushes and Silver Care Toothbrush Refills - For the Public

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Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Norwex Enviro Products Inc.
Contact the company for a copy of any references, attachments or enclosures.

PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on Silver Care Toothbrushes and Silver Care Toothbrush Refills

March 19, 2009

Subject: Medical Device Recall - Warning Label Addition

Full Product Description

• Silver Care Toothbrush (medium) #22963/354060
• Silver Care Refills 2 pkg. (medium) # 22931/354061
• Silver Care Toothbrush (soft) # 22964/354050
• Silver Care Refills 2 pkg. (soft) # 22932/354051

Hazard Identified

As a result of the investigation into a complaint received on February 6, 2008 where the improper use of the toothbrush led to the swallowing of the removable head. A health hazards evaluation determined that the device may pose a possible choking or swallowing hazard to children under three or individuals that would normally require supervision or assistance while brushing their teeth. Norwex has determined that a warning should be added to prevent reoccurrence of such an incident. The warning label will read

Corrective Action

Consumers should immediately take product away from individuals identified in the above warning and dispose of the products in their regular household trash. The product does not have to be returned; it is safe for all other people (with the exception to the individuals identified above) to continue using.

As a Norwex Consultant it is mandatory you follow the recall instructions provided below.

• Health Canada requires that all unopened stock must be relabelled.
• Consultants must contact customers who have purchased toothbrushes and refills in the past two years. Consultants are required to keep a record of all correspondence in regards to this recall notification, including faxes, e-mails, a list of phone calls and any personal visits made. We suggest you print the "Customer Notifications Report" and use it to document your notifications. When all customers have been contacted, complete the "Recall Response Form" and fax or mail. Labels will be sent upon completion and submission of the Recall Response Form. You will receive labels in both French and English.
• Recall Notifications and other technical product information will be available at www.Norwex.ca
• Follow the instructions provided and complete the "Recall Response Form" there you can fill it in and submit it or print the form and fill it out and fax toll free 1-877-622-3620 or mail it on or before March 27, 2009 to:
  Norwex, Attention Gerd Doroshuk, Medical Device Recall, Box 714 Dauphin, MB R7N 3B3

Number Sold
Approximately 70,402 units were sold across Canada.

Time Period Sold
These products were sold between January 2007 and March 2009 by Norwex Consultant across Canada

Distributed by Norwex Enviro Products - 871 Whitmore Ave E. Dauphin, MB R7N 3B3

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious specific adverse incident or other serious or unexpected adverse incidents in patients using Silver Care Toothbrushes and Silver Care Toothbrush Refills should be reported to Norwex Enviro Products Inc. or Health Canada at the following addresses: