Device product
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Z-0766-2023
Product summary
- 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
microbial growth