Drug recall
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF…
FDA recall event 72290 · Class II · Ivoclar A. G.
Key facts
| Event ID | 72290 |
|---|---|
| Recall numbers | Z-0213-2016 |
| Recalling firm | Ivoclar A. G. |
| Product type | Devices |
| Products | Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during… |
| Initiation date | Oct 7, 2015 |
| Report date | Nov 11, 2015 |
| Termination date | Jun 14, 2016 |
| City | Schaan |
| Country | Liechtenstein |
| FEI number | 3002808636 |
At a glance
- 1–9 Products in this recall
- 1–9 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: