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

FDA Recall #Z-0766-2023 — Class II — December 2, 2022

Recall #Z-0766-2023 Date: December 2, 2022 Classification: Class II Status: Ongoing

Product Description

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.

Recalling Firm

Tomy International Inc. — Canton, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

approx 55,000 North America

Distribution

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

Code Information

UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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