Device recall
Z-0955-2013: Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used…
FDA device recall · Class I · Vascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-0955-2013 |
|---|---|
| Recall event | 64511 |
| Product | Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to… |
| Product code | DTL |
| Recalling firm | Vascular Solutions, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 5, 2013 |
| 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