Device recall
Z-0833-2007: TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm…
FDA device recall · Class II · Kensey Nash Corp
Key facts
| Recall number (Z-number) | Z-0833-2007 |
|---|---|
| Recall event | 37701 |
| Product | TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow… |
| Product code | FRO |
| Recalling firm | Kensey Nash Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 30, 2007 |
| 510(k) numbers | K061772 |
| FEI number | 1000307073 |
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