Drug recall
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard…
FDA recall event 65119 · Class II · Angiodynamics, Inc.
Key facts
| Event ID | 65119 |
|---|---|
| Recall numbers | Z-1405-2013, Z-1406-2013 |
| Recalling firm | Angiodynamics, Inc. |
| Product type | Devices |
| Products | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer…, AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit…, AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit… |
| Initiation date | Apr 30, 2013 |
| Report date | Jun 5, 2013 |
| Termination date | Nov 9, 2016 |
| City | Queensbury |
| State | NY |
| Country | United States |
| FEI number | 1319211 |
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: