Drug recall
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or…
FDA recall event 92585 · Class II · Argon Medical Devices, Inc
Key facts
| Event ID | 92585 |
|---|---|
| Recall numbers | Z-2239-2023 |
| Recalling firm | Argon Medical Devices, Inc |
| Product type | Devices |
| Products | Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism. |
| Initiation date | Jun 8, 2023 |
| Report date | Aug 2, 2023 |
| City | Athens |
| State | TX |
| Country | United States |
| FEI number | 1625425 |
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: