Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syrin
FDA device recall Z-0425-2015 · posted 2014-11-24 · Terminated
Recall details
- Recalling firm
- Discus Dental LLC
- Reason for recall
- Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.
- Action taken
- Cease distribution of the product immediately and contact patients who may have received the product from April 1, 2014. Patients who are still in possession of Relief ACP Oral Care Gel should return affected product to dentinal office. Discus Dental is offering a non-cost replacement for all affected product, including free shipping. To remedy the situation take the following steps: 1. Contact the patients who have received affected product after April 1, 2014 either by letter or telephone, and instruct them to cease use of the product immediately and return any remaining product. 2. Please use Attachment A: Product Shipped, Acknowledgement and Response Form to document the quantity of affected lots of product being returned to Discus Dental LLC. Go to www.philips.com/discus-reliefgel and enter the requested information with contact details. 3. Please contact Discus Dental customer service at CustomerServicePhone if you have any questions and to arrange for replacement products and prepaid return shipping label.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- LBH
- Quantity affected
- 20,251 distributed in U.S. on nationwide level and 14,653 internationally
- Distribution
- Worldwide distribution including Nationwide (U.S.) and the countries of New Zealand, Australia, Canada, Germany, Switzerland, Italy, Austria, Finland, South Africa, United Arab Emirates, Korea, Turkey
- Date initiated
- 2014-10-24
- Date posted
- 2014-11-24
- Date terminated
- 2015-04-14
- Location
- Ontario, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RELIEF ACP ORAL CARE GEL (K062176) | Discus Dental, Inc. | 2007-01-10 |