Device recall
Z-0535-2007: FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division…
FDA device recall · Class II · St. Jude Medical / Daig Division
Key facts
| Recall number (Z-number) | Z-0535-2007 |
|---|---|
| Recall event | 36605 |
| Product | FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850. |
| Product code | DYB |
| Recalling firm | St. Jude Medical / Daig Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 25, 2007 |
| 510(k) numbers | K964518 |
| FEI number | 2182269 |
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