Drug recall
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is…
FDA recall event 76448 · Class II · Abbott Vascular
Key facts
| Event ID | 76448 |
|---|---|
| Recall numbers | Z-1202-2017 |
| Recalling firm | Abbott Vascular |
| Product type | Devices |
| Products | StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip. |
| Initiation date | Feb 10, 2017 |
| Report date | Feb 22, 2017 |
| Termination date | Dec 6, 2017 |
| City | Temecula |
| State | CA |
| Country | United States |
| FEI number | 2024168 |
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: