Date Initiated by Firm |
January 25, 2006 |
Date Posted |
February 09, 2006 |
Recall Status1 |
Terminated 3 on August 10, 2006 |
Recall Number |
Z-0456-06 |
Recall Event ID |
34467 |
Product Classification |
Ring, Teething, Fluid-Filled - Product Code KKO
|
Product |
Disney Baby Soft Cool Ring Teether Style # Y1470 |
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
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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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