Drug recall
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or…
FDA recall event 86627 · Class II · Angiodynamics, Inc.
Key facts
| Event ID | 86627 |
|---|---|
| Recall numbers | Z-0418-2021 |
| Recalling firm | Angiodynamics, Inc. |
| Product type | Devices |
| Products | Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component |
| Initiation date | Oct 14, 2020 |
| Report date | Nov 11, 2020 |
| Termination date | Oct 19, 2021 |
| 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: