Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Summary
The FDA issued a Class II for Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L by Tomy International Inc.. 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 .
Details
Source
Device Recall
External ID
Z-0766-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Lot/Code Info: UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01
Quantity Affected: approx 55,000 North America
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-02
Company
Canton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tomy International Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tomy International Inc. have FDA actions?
This is the only FDA action we have on record for Tomy International Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0766-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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