Drug recall
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or…
FDA recall event 68073 · Class II · Arrow International Inc
Key facts
| Event ID | 68073 |
|---|---|
| Recall numbers | Z-1713-2014 |
| Recalling firm | Arrow International Inc |
| Product type | Devices |
| Products | Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage. |
| Initiation date | Apr 14, 2014 |
| Report date | Jun 11, 2014 |
| Termination date | Oct 14, 2016 |
| City | Reading |
| State | PA |
| Country | United States |
| FEI number | 2518433 |
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: