Device recall
Z-0391-2007: ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation…
FDA device recall · Class II · Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Key facts
| Recall number (Z-number) | Z-0391-2007 |
|---|---|
| Recall event | 37019 |
| Product | ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244 |
| Product code | DTL |
| Recalling firm | Abbott Vascular-Cardiac Therapies dba Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2012 |
| 510(k) numbers | K854261, K861847 |
| FEI number | 2024168 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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