Recall Z-1213-2015— Norwex Usa Inc

Name: FDA recall Z-1213-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-03

Class II · Terminated

Class II FDA medical device recall by Norwex Usa Inc, initiated 2015-02-03, terminated 2016-06-27. It names one FDA 510(k) clearance: K102871. 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.. Reason: The toothbrush head can potentially disengage from the handle..

Recalling firm: Norwex Usa Inc
Classification: Class II
Status: Terminated
Initiated: 2015-02-03
Terminated: 2016-06-27
Firm location: Addison, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSHPiave Spazzolificio S.P.A.·cleared 2011-10-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

The toothbrush head can potentially disengage from the handle.

Data sourced from openFDA. This site is unofficial and independent of the FDA.