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U.S. Department of Health and Human Services

Class 1 Device Recall Luv N' Care Ltd Gel Filled Teethers

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  Class 1 Device Recall Luv N' Care Ltd Gel Filled Teethers see related information
Date Initiated by Firm July 17, 2009
Date Posted August 12, 2009
Recall Status1 Terminated 3 on February 28, 2013
Recall Number Z-1878-2009
Recall Event ID 52708
Product Classification Gel Filled Teethers - Product Code KKO
Product 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.
Code Information UPC codes:  48526-00451 Nuby 48526-00452 Nuby 48526-00453 Nuby 48526-00454 Nuby 48526-00455 Nuby 48526-00459 Nuby 48526-00467 Nuby 48526-00472 Nuby 48526-00473 Nuby 48526-00482 Nuby 48526-00483 Nuby 48526-00487 Nuby 48526-00490 Nuby 48526-00519 Nuby 48526-00521 Nuby 48526-87115 Cottontails 48526-91511 Playskool and 48526-91660 Cottontails. 
Recalling Firm/
Manufacturer		 Luv N' Care Ltd
3030 Aurora Ave Fl 2nd
Monroe LA 71201-7295
For Additional Information Contact Joseph H. Hakim
318-338-3172
Manufacturer Reason
for Recall		 Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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