Device recall
Z-1822-2012: Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products…
FDA device recall · Class II · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-1822-2012 |
|---|---|
| Recall event | 62120 |
| Product | Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print… |
| Product code | KLE |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2012 |
| 510(k) numbers | K063558 |
| FEI number | 1718912 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database