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U.S. Department of Health and Human Services

Class 2 Device Recall Lamaze Chill Teether

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  Class 2 Device Recall Lamaze Chill Teether see related information
Date Initiated by Firm December 02, 2022
Date Posted December 22, 2022
Recall Status1 Open3, Classified
Recall Number Z-0766-2023
Recall Event ID 91177
Product Classification Ring, teething, fluid-filled - Product Code KKO
Product Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Code Information UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01
Recalling Firm/
Manufacturer		 Tomy International Inc.
45 Shawmut Rd Fl 3
Canton MA 02021-1400
For Additional Information Contact Customer Contact
866-725-4407
Manufacturer Reason
for Recall		 Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.
FDA Determined
Cause 2		 Process control
Action On 12/2/2022, the firm notified customers with Medical Device Recall letters. Customers were instructed to identify any affected product on hand and dispose of all affected products. The firm may provide payment credits to customers for disposed units. Customers should notify downstream accounts if affected lots were distributed to third parties. Customers/Retailers were provided with recall posters to post in a conspicuous location for consumers, to ensure that anyone who purchased a product from the affected lots is notified that they should stop using and dispose of the product. Consumers should immediately stop using affected product and dispose of it in the trash. Do not return the item to the store. Production code can be found directly on the back of the packaging and on the product itself. For more information, consumers can contact TOMY International, Inc. by telephone at 1-866-725- 4407 from 8:00 a.m. and 4:00 p.m. CT Monday through Friday or visit https://recall.tomy.com/chillteether.html (web URL updated 9/8/23).
Quantity in Commerce approx 55,000 North America
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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