Recall Z-0766-2023 ยท KKO Ring, Teething, Fluid-Filled
Tomy International Inc.
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
| Date | Dec 22, 2022 (initiated Dec 2, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On 12/2/2022, the firm notified customers with Medical Device Recall letters. Customers were instructed to identify any affected product on hand and dispose of all affected products. The firm may provide payment credits to customers for disposed units. Customers should notify downstream accounts if affected lots were distributed to third parties. Customers/Retailers were provided with recall posters to post in a conspicuous location for consumers, to ensure that anyone who purchased a product from the affected lots is notified that they should stop using and dispose of the product. Consumers |
| Quantity | approx 55,000 North America |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.