Medical Devices
Luv N' Care Gel-Filled Teethers – "Nuby," "Cottontails," and "Playschool"
| Recall Class: | Class I | ||||||||||||||||||||||||||||||||||||||
| Date Recall Initiated: |
July 17, 2009 | ||||||||||||||||||||||||||||||||||||||
| Product: |
Gel-Filled Teethers, various shapes and sizes, marketed under the names, "Nuby," "Cottontails," and "Playschool" The recall includes the following products:
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| Use: | Teethers are used in infants for teething relief. | ||||||||||||||||||||||||||||||||||||||
| Recalling Firm: | Luv N' Care Ltd. 3030 Aurora Avenue, 2nd Floor Monroe, Louisiana 71201-7295 |
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| Reason for Recall: | These teethers may contain harmful bacteria (Bacillus circulans and Bacillus subtilis) in the gel. Use of this product may result in diarrhea, respiratory illness, serious infection, and death. | ||||||||||||||||||||||||||||||||||||||
| Public Contact: | Consumers with questions may contact the company's consumer service at 1-800-256-2399 ext. 3106, Monday-Friday, between 8am and 5pm Central Time. | ||||||||||||||||||||||||||||||||||||||
| FDA District: | New Orleans | ||||||||||||||||||||||||||||||||||||||
| FDA Comments: |
Stop using these teething rings immediately. The company stopped distributing these products and has notified its distributors to return the products. Consumers are urged to return the products to the place of purchase for a full refund. The company issued a press release on July 17, 2009. For more information, see Useful Links below. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Useful Links: |