Events

Recall of Device Recall Crest SpinBrush ProWhitening

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Proctor & Gamble Co.

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
    30413
  • Event Risk Class
    Class 2
  • Event Number
    Z-0375-05
  • Event Initiated Date
    2004-11-11
  • Event Date Posted
    2004-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35822
  • 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
    Toothbrush, Powered - Product Code JEQ
  • Reason
    Market withdrawal of crest spinbrush pro-whitening. the firm has determined that there is a quality issue in certain production that may allow the circular brush at the tip of the brush head to become detached over time in a very small number of brushes.
  • Action
    The firm notified distributors by letter on November 11, 2004. Distributors are asked to contact all of their retail stores.

Device

Device Recall Crest SpinBrush ProWhitening
  • Model / Serial
    All Codes.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening Medium Refills, UPC 7 66878 00194 4.
  • Manufacturer
    Proctor & Gamble Co

Manufacturer

Proctor & Gamble Co
  • Manufacturer Address
    Proctor & Gamble Co, 2 Procter And Gamble Plz, Cincinnati OH 45202-3315
  • Source
    USFDA