Device recall
Z-1219-06: TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm…
FDA device recall · Class II · Kensey Nash Corp
Key facts
| Recall number (Z-number) | Z-1219-06 |
|---|---|
| Recall event | 35680 |
| Product | TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter… |
| Product code | NFA |
| Recalling firm | Kensey Nash Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2006 |
| 510(k) numbers | K042040 |
| FEI number | 1000307073 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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