The Recall Desk
LowFDA (Food)·F-1271-2013·Announced 2013-04-03

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.

What this means for you

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
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

Distributed in 13 states: