Device recall
Z-0108-2015: St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308…
FDA device recall · Class II · St Jude Medical
Key facts
| Recall number (Z-number) | Z-0108-2015 |
|---|---|
| Recall event | 69499 |
| Product | St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents. |
| Product code | DYB |
| Recalling firm | St Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 25, 2015 |
| 510(k) numbers | K954317 |
| FEI number | 3007562768 |
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