Ultradent Recalls Opalescence Treswhite Supreme Peach Patient Kits
Ultradent Products, Inc. is recalling 104 units of Opalescence Treswhite Supreme Peach Patient Kits due to incorrect shelf-life labeling.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a documentation and labeling error regarding the expiration date.
Plain-English summary
Ultradent Products, Inc. is recalling 104 units of the Opalescence Treswhite Supreme Peach Patient Kit. The recall was initiated because the product was packaged into kits labeled with a shelf life of 2103-05, whereas the correct shelf life is 2013-05.
The affected product is identified by Lot B6LZS and Part number 5705. The units were distributed to 13 U.S. states (AL, CA, GA, IL, IN, MA, MD, MI, NJ, OK, PA, SC, UT) and 12 international distributors in Germany, China, France, and Spain.
Consumers and healthcare providers should stop using the affected kits and contact Ultradent Products, Inc. for further instructions.
The recalled product
- Product
- Opalescence Treswhite Supreme Peach Patient Kit
- Manufacturer
- Ultradent Products, Inc.
- Hazard
- Affected units
- 104
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot B6LZS
- Part number 5705
Distribution
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