Drug recall
UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal…
FDA recall event 75796 · Class II · Ultradent Products, Inc.
Key facts
| Event ID | 75796 |
|---|---|
| Recall numbers | Z-0704-2017 |
| Recalling firm | Ultradent Products, Inc. |
| Product type | Devices |
| Products | UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products… |
| Initiation date | Nov 17, 2016 |
| Report date | Dec 14, 2016 |
| Termination date | Jun 5, 2017 |
| 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: