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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-0458-06
Recall Event ID 34467
Product Classification Ring, Teething, Fluid-Filled - Product Code KKO
Product The First Years Cool Animal Teether/Fish, Zebra and Dinosaur designs
Style #Y1473
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 2
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.
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