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U.S. Department of Health and Human Services

Class 2 Device Recall Clarisonic Skin Care System

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 Class 2 Recall
Clarisonic Skin Care System
see related information
Date Posted November 16, 2007
Recall Status1 Open
Recall Number Z-0182-2008
Recall Event ID 44944
Product Classification Cleaner, Ultrasonic, Medical Instrument - Product Code FLG
Product Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience Laboratories, Inc., 13222 SE 30th St., Bellevue, WA 98005
Code Information All codes prior to 07177xx. (June 26, 2007). Lot codes are as follows: YYDDDxx, where DDD is the ordinal date. Handle codes are clearly printed on the bottom of the handle. All codes lot codes after, and including 07177xx are not subject to recall, and are followed by a "T" or "J" for ease in identification
Recalling Firm/
Manufacturer
Pacific Bioscience Lab, Inc.
13222 Se 30th St Ste A1
Bellevue, Washington 98005
For Additional Information Contact David Giuliani
425-283-1776
Manufacturer Reason
for Recall
Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.
FDA Determined
Cause 2
DESIGN: Device Design
Action On August 30, 2007, the firm issued a press statement via PR Newswire and The Associated Press. They also posted a Recall Notice on their website (www.Clarisonic.com) requesting consumers to return their affected products for an exchange. All retailers and professional resellers were notified by telephone, E mail and/or letter and asked to return unsold inventory, as well as, post the provided point of sales notices and send provided post cards to known customers requesting exchange of recalled product. All users can contact the firm via the website or by phone at 1-866-378-7360 (6 am-6pm, M-F, Pacific Time) to arrange for the device exchange.
Quantity in Commerce 97,500
Distribution Worldwide Distribution - including USA and countries of Japan and Canada. Units were distributed to retailers and professional skin care clinics throughout the USA. In addition, units were distributed to one distributor in Japan and to 4 clinics in Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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