Drug recall
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
FDA recall event 72945 · Class II · Bard Peripheral Vascular Inc
Key facts
| Event ID | 72945 |
|---|---|
| Recall numbers | Z-0737-2016 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Product type | Devices |
| Products | Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys. |
| Initiation date | Mar 13, 2015 |
| Report date | Feb 10, 2016 |
| Termination date | Feb 1, 2016 |
| City | Tempe |
| State | AZ |
| Country | United States |
| FEI number | 2020394 |
At a glance
- 1–9 Products in this recall
- 10–99 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: