Recall Z-0766-2023— Tomy International Inc.
Class II · Ongoing
Class II FDA medical device recall by Tomy International Inc., initiated 2022-12-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L. 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..
- Recalling firm
- Tomy International Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-02
- Firm location
- Canton, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.