Recall Z-0182-2008 ยท FLG Cleaner, Ultrasonic, Medical Instrument
Pacific Bioscience Lab, Inc.
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
| Date | Nov 16, 2007 (initiated Jul 3, 2007) |
| Status | Terminated |
| 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. |
| Root cause | 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- |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.