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U.S. Department of Health and Human Services

Class 1 Device Recall First Years

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  Class 1 Device Recall First Years see related information
Date Initiated by Firm January 25, 2006
Date Posted February 09, 2006
Recall Status1 Terminated 3 on August 10, 2006
Recall Number Z-0460-06
Recall Event ID 34467
Product Classification Ring, Teething, Fluid-Filled - Product Code KKO
Product Sesame Beginnings Chill & Chew Teether
Style #Y3095
Code Information All codes
Recalling Firm/
RC2 Brands Inc., The First Years
100 Technology Drive
Suite 2A
Stoughton MA 02072
For Additional Information Contact James Pesaturo
Manufacturer Reason
for Recall
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
FDA Determined
Cause 2
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.
Distribution Nationwide Foreign: Canada, UK, Australia, Mexico
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.