Events

Recall of Device Recall First Years

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RC2 Brands Inc., The First Years.

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
    34467
  • Event Risk Class
    Class 1
  • Event Number
    Z-0460-06
  • Event Initiated Date
    2006-01-25
  • Event Date Posted
    2006-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43893
  • 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
    Ring, Teething, Fluid-Filled - Product Code KKO
  • Reason
    Liquid filled infant teething ring contaminated with pseudomonas aeruginosa and pseudomonas putida.
  • Action
    RC2/The First Years initiated recall by email with recall letter on 1/27 /06. Buyers will advise retail stores to remove product from retail shelves and return to First Years for replacement. The firm is posting the recall to their website: www.thefirstyears.com. A Press Release was issued to AP on 1/27/05.

Device

Device Recall First Years
  • Model / Serial
    All codes
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada, UK, Australia, Mexico
  • Product Description
    Sesame Beginnings Chill & Chew Teether || Style #Y3095
  • Manufacturer
    RC2 Brands Inc., The First Years

Manufacturer

RC2 Brands Inc., The First Years
  • Manufacturer Address
    RC2 Brands Inc., The First Years, 100 Technology Drive, Suite 2A, Stoughton MA 02072
  • Source
    USFDA