Drug recall
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching…
FDA recall event 78479 · Class II · Cosmedent, Inc.
Key facts
| Event ID | 78479 |
|---|---|
| Recall numbers | Z-0741-2018 |
| Recalling firm | Cosmedent, Inc. |
| Product type | Devices |
| Products | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. |
| Initiation date | Sep 28, 2017 |
| Report date | Mar 7, 2018 |
| Termination date | Oct 5, 2020 |
| City | Chicago |
| State | IL |
| Country | United States |
| FEI number | 1450653 |
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: