Drug recall
Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch…
FDA recall event 62120 · Class II · Ultradent Products, Inc.
Key facts
| Event ID | 62120 |
|---|---|
| Recall numbers | Z-1822-2012 |
| Recalling firm | Ultradent Products, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products… |
| Initiation date | May 24, 2012 |
| Report date | Jun 27, 2012 |
| Termination date | Aug 15, 2012 |
| City | South Jordan |
| State | UT |
| Country | United States |
| FEI number | 1718912 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: