Device recall
Z-0623-2017: Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer…
FDA device recall · Class II · Greatbatch Medical
Key facts
| Recall number (Z-number) | Z-0623-2017 |
|---|---|
| Recall event | 75145 |
| Product | Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator… |
| Product code | DYB |
| Recalling firm | Greatbatch Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2017 |
| 510(k) numbers | K071574 |
| FEI number | 2183787 |
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