 |
 |
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | FDA Centennial
|
FOR IMMEDIATE RELEASE |
Media
Inquiries: |
The U.S. Food and Drug Administration (FDA) is advising consumers to stop using liquid-filled children's teething rings manufactured by RC2 Brands (The First Years) because the liquid contained in these rings is contaminated with bacteria that may cause serious illness if swallowed by babies, enters the lungs, or is absorbed through a cut in the mouth.
The risk of illness is especially high in infants whose immune systems are compromised by underlying issues such as malnutrition, blood problems, or as a result of cancer therapy.
RC2 Brands (The First Years), which is located in Stoughton, Massachusetts, stopped distributing the teethers and began a recall of these products in January 2006.
"FDA is closely monitoring the recall to ensure that all these teething rings are removed from the market and that consumers are alerted to the problem," said Dr. Daniel Schultz, Director of FDA's Center for Devices and Radiological Health. "The agency is also taking a careful look at other RC2/The First Year products to determine if any others are contaminated with the bacteria."
The teething rings were sold nationwide between July 2005 and January 2006 at major retailers, and grocery, drug, and specialty stores. Approximately 352,000 have been distributed in the United States. The specific products subject to the recall are:
FDA has determined that the firm's action constitutes a Class I recall, a situation in which there is a reasonable chance that use of the product will cause serious health problems or death. To date, the firm has received 105 complaints of fluid leakage, 14 reports of sharp edges that resulted in 9 incidents of cuts, and 2 reports of babies biting through the rings. The teething rings are manufactured in Hong Kong and have been sold in both the United States and Canada.
The firm is asking consumers who purchased one of the recalled teethers to place it in a plastic bag and return it to:
Parent Service Center
RC2/The First Years
100 Technology Center Dr.
Stoughton, Mass., 02072
For additional information, consumers can contact the firm's service center at 1-866-725-4407, or go to the firm's web site: www.thefirstyears.com.
Any adverse reactions or quality problems experienced with use of these teethers should be reported to the FDA MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or on the MedWatch web site at www.fda.gov/medwatch.
####
Firm Press Release (Jan. 27, 2006)
RSS Feed for FDA News Releases [what's this?]
Get
free weekly updates about FDA press releases, recalls, speeches, testimony
and more.