• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall First Years

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall First Yearssee related information
Date Initiated by FirmJanuary 25, 2006
Date PostedFebruary 09, 2006
Recall Status1 Terminated 3 on August 10, 2006
Recall NumberZ-0457-06
Recall Event ID 34467
Product Classification Ring, Teething, Fluid-Filled - Product Code KKO
ProductDisney Baby Soft Cool Ring Teether Style # Y1490
Code Information All codes
Recalling Firm/
Manufacturer
RC2 Brands Inc., The First Years
100 Technology Drive
Suite 2A
Stoughton MA 02072
For Additional Information ContactJames 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
ActionRC2/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.
DistributionNationwide Foreign: Canada, UK, Australia, Mexico
Total Product Life CycleTPLC 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.
-
-