FDA Recall Terminated

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

Recall: Z-0182-2008 · Initiated July 3, 2007

Recall

Recall Number
Z-0182-2008
Event Number
44944
Firm
Pacific Bioscience Lab, Inc.
FEI Number
3005492502
Product Code
FLG
Status
Terminated
Root Cause
Device Design
Initiated
July 3, 2007
Posted
November 16, 2007
Terminated
December 13, 2010
Address
13222 Se 30th St, Ste A1, Bellevue, WA, 98005

Description

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

Reason

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.

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.

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.

Quantity

97,500