Device recall
Z-1275-2016: Guardian II Hemostasis Valve, models 8210 and 8211. The following models are…
FDA device recall · Class I · Vascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-1275-2016 |
|---|---|
| Recall event | 73553 |
| Product | Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into… |
| Product code | DTL |
| Recalling firm | Vascular Solutions, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 19, 2016 |
| 510(k) numbers | K122301 |
| 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