Recall Z-1878-2009 ยท KKO Ring, Teething, Fluid-Filled
Luv N' Care Ltd
Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool. This product is intended for use by infants for medical purposes to soothe gums during the teething process.
| Date | Aug 12, 2009 (initiated Jul 17, 2009) |
| Status | Terminated |
| Reason | Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis. |
| Root cause | PMA |
| Action | The firm initiated their recall by telephone and email, and followed with letters to their consignees directing a recall to the consumer level. Consumers are urged to stop using the affected product and discard or return to the place of purchase. Consumers with questions about the recall may contact Luv N' Care, LTD by calling 1-800-256-2399. The firm issued a Press Release on July 17, 2009. Press Release about this recall is located on the website address: http://www.fda.gov/Safety/Recalls/ucm172689.htm. |
| Quantity | 546,320 units |
| Distribution | Worldwide Distribution -- US (states of NY, IA, WI, IL, FL, NE, OH, MI, TX, NY, RI, and VA), Canada, Haiti, West Indies, Surinam, Antilles, Uruguay, Mexico, Bermuda, Canada, Dominican Republic, Dutch West Indies, Bahamas, North Antilles and Paraguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.