TOMY International, Inc. URGENT – MEDICAL DEVICE RECALL Lamaze Chill TeetherTM

Stater Bros. Markets is NOT affected by this recall

“The purpose of this letter is to advise you that TOMY International, Inc. (the “Company”) is
voluntarily recalling Lamaze Chill Teether Item number – Y5288L, UPC 7146305288, Production
Codes E1920ALP01 & K1920ALP01 (which we are referring to as the allegedly “Affected Lots”).

Reason for the Voluntary Recall
These two Affected Lots of the product are being recalled due to observed inconsistencies in
laboratory test results, which suggested the presence of microbial growth in the fluid that is found
inside of the device. At least one sample taken from lot K1920ALP01 tested positive for
Sphingomonas sp., while at least one sample from lot E1920ALP01 tested positive for
Staphylococcus epidermidis.


No illnesses or other adverse events have been reported to the Company in relation to these two
Affected Lots. The Company is taking this voluntary action to remove any remaining units of the
potentially Affected Lots from commerce out of an abundance of caution and in the interest of the
public health given the vulnerable nature of the intended use population (infants and babies).


Risk to Health
In the majority of the population, it is unlikely that a teething ring that has liquid in its interior cavity
that is potentially contaminated with microbial growth could cause any negative impacts on or
adverse health effects to the user. However, if a compromised product is used by a child with a
weakened immune system, an infection or other illness could occur. In the event that an infant
were to break the barrier of the liquid filled-teether, ingest contaminated water, and develop an
infection, it is expected that standard antibiotic therapy would successfully treat such a resulting
infection in both healthy and immunocompromised individuals.
Affected units of the product that are the subject of this recall notice can be identified by batch
code on product and/or packaging. Product labeling is enclosed for your reference as well.

For more information, consumers can contact TOMY International, Inc. by telephone at 1-866-725-
4407 from 8:00 a.m. and 4:00 p.m. CT Monday through Friday or visit https://recall.tomy.com
Adverse reactions or quality problems experienced with the use of this product may be reported to the
FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.