FDA-Device2022-12-28Class II

Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L

Tomy International Inc.
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.
Affected count
approx 55,000 North America
Manufactured in
45 Shawmut Rd Fl 3, Canton, MA, United States
Products
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0766-2023

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