Drug recall
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without…
FDA recall event 83017 · Class II · Leventon S. A. U.
Key facts
| Event ID | 83017 |
|---|---|
| Recall numbers | Z-2360-2019 |
| Recalling firm | Leventon S. A. U. |
| Product type | Devices |
| Products | DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market. |
| Initiation date | May 23, 2019 |
| Report date | Sep 4, 2019 |
| Termination date | Jun 8, 2020 |
| City | Barcelona |
| Country | Spain |
| FEI number | 3002807471 |
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: