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Recall Observatory FDA recall evidence

Device product

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

Z-0766-2023

December 02, 2022

Class II

Product summary

Firm
Tomy International Inc.
Event
Event 91177
Status
Ongoing
Classification
Class II
Quantity
approx 55,000 North America
Official record key
device-enforcement:Z-0766-2023

Official wording

Reason: 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.

Code information: UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01

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

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial growth