Medical device recalls Moderate risk

Tomy International Inc. recalls Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L

Recall date
December 2, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0766-2023
FDA classification
Class II
Brand / firm
Tomy International Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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