Recall Z-0661-2020 ยท LBH Varnish, Cavity
Young Dental Manufacturing Co, LLC
Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
| Date | Oct 30, 2019 |
| Status | Open, Classified |
| Reason | Product shelf life may be shorter than that indicated on the label. |
| Root cause | Process control |
| Action | Notification by letter to be made to customer via certified mail. Customers are instructed to return or scrap the affected product. Multiple attempts will be made to contact customers. Returned product will be destroyed. For recall inquiries, contact 224-622-7191. |
| Quantity | Batch 84702 - 6500 units; Batch 72766 - 6500 units |
| Distribution | US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153334 | Oral-B 5% Sodium Fluoride Varnish Young Dental Manufacturing Co. 1, LLC, May 20, 2016 |