Device recall
Z-2400-2012: Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve…
FDA device recall · Class II · Vascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-2400-2012 |
|---|---|
| Recall event | 63098 |
| Product | Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F… |
| Product code | DTL |
| Recalling firm | Vascular Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 4, 2012 |
| 510(k) numbers | K092711, K101113 |
| FEI number | 3002827704 |
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