Device recall
Z-0778-2017: ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog…
FDA device recall · Class III · Angiodynamics, Inc.
Key facts
| Recall number (Z-number) | Z-0778-2017 |
|---|---|
| Recall event | 75420 |
| Product | ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick |
| Product code | DYB |
| Recalling firm | Angiodynamics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 18, 2018 |
| 510(k) numbers | K051655 |
| FEI number | 1319211 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database