Drug recall
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
FDA recall event 71161 · Class II · Amerx Health Care Corp.
Key facts
| Event ID | 71161 |
|---|---|
| Recall numbers | Z-1797-2015 |
| Recalling firm | Amerx Health Care Corp. |
| Product type | Devices |
| Products | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Nonapproved labeling claims (Sterile) |
| Initiation date | Feb 25, 2015 |
| Report date | Jun 24, 2015 |
| Termination date | Oct 3, 2016 |
| City | Clearwater |
| State | FL |
| Country | United States |
| FEI number | 1000525408 |
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: