Class 1 Device Recall First Years

• Date Initiated by Firm: January 25, 2006
• Date Posted: February 09, 2006
• Recall Status: Terminated 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/ Manufacturer: RC2 Brands Inc., The First Years; 100 Technology Drive; Suite 2A; Stoughton MA 02072
• For Additional Information Contact: James Pesaturo; 781-341-6250
• Manufacturer Reason for Recall: Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
• FDA Determined Cause: Other
• 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.