Recall -- Firm Press Release
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Ultimate Dental and Coltène/Whaledent Inc. Issue Allergy Alert on Undeclared Latex in One Lot of Ultimate Non-Latex Dam
FOR IMMEDIATE RELEASE - December 19, 2013 - Ultimate Dental of Memphis, TN and Coltène/Whaledent Inc. of Cuyahoga Falls, OH are recalling one lot of Ultimate Non-Latex Dam distributed by Ultimate Dental, A Division of Endoco, Inc. because it contains undeclared latex. People who have allergies to latex may run the risk of serious or life-threatening allergic reaction if they come in contact with this product. No injuries have been reported to date.
The misbranding was discovered while investigating a customer complaint for unexpected appearance. Coltène/Whaledent Inc. notified the FDA after becoming aware that the unexpected appearance was due to the presence of product containing latex. The issue involves 74 boxes of Ultimate Non-Latex Dam part number 1884-10840 lot 103G2. The product is only sold to dental professionals.
Consumers who have Lot 103G2 of Ultimate Dental Non-Latex Dam should immediately stop using this product and arrange to return the remaining product to Coltène/Whaledent Inc. Lot 103G2 was manufactured and distributed in June 2013. Of the 74 boxes distributed, a total of 42 boxes have already been physically quarantined.
Consumers with questions may contact Coltène/Whaledent Inc. at 800-221-3046 Monday through Friday between the hours of 8:00AM – 5:00PM EST. Consumers may also contact the company via email at firstname.lastname@example.org.
Adverse reactions experienced with the use of this product may be reported to the FDA:
- Online at http://www.fda.gov/safety/MedWatch/HowToReport/defaul.htm, or
- Call FDA at 1-800-FDA-1088