Device recall
Z-0968-03: Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011
FDA device recall · Class II · MedAmicus,Inc
Key facts
| Recall number (Z-number) | Z-0968-03 |
|---|---|
| Recall event | 26475 |
| Product | Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011 |
| Product code | DYB |
| Recalling firm | MedAmicus,Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 2, 2004 |
| 510(k) numbers | K021044 |
| 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