FDA recall Z-0766-2023

Tomy International Inc. · Class II · device

Product

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

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.

Key facts

Status
Ongoing
Initiation date
2022-12-02
Report date
2022-12-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Canton, MA, United States

Primary source

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