Drug recall
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing…
FDA recall event 72019 · Class II · Revmedx Inc
Key facts
| Event ID | 72019 |
|---|---|
| Recall numbers | Z-2762-2015 |
| Recalling firm | Revmedx Inc |
| Product type | Devices |
| Products | XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If… |
| Initiation date | Aug 12, 2015 |
| Report date | Sep 23, 2015 |
| Termination date | Sep 17, 2015 |
| City | Wilsonville |
| State | OR |
| Country | United States |
| FEI number | 3009035955 |
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: