Events

Recall of Device Recall Clarisonic Skin Care System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pacific Bioscience Lab, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    44944
  • Event Risk Class
    Class 2
  • Event Number
    Z-0182-2008
  • Event Initiated Date
    2007-07-03
  • Event Date Posted
    2007-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64562
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ultrasonic Cleaner -- Medical Instrument - Product Code FLG
  • 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.

Device

Device Recall Clarisonic Skin Care System
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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
  • Manufacturer
    Pacific Bioscience Lab, Inc.

Manufacturer

Pacific Bioscience Lab, Inc.
  • Manufacturer Address
    Pacific Bioscience Lab, Inc., 13222 Se 30th St Ste A1, Bellevue WA 98005
  • Source
    USFDA