Device recall
Z-1611-2023: Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000…
FDA device recall · Class II · TELEFLEX LLC
Key facts
| Recall number (Z-number) | Z-1611-2023 |
|---|---|
| Recall event | 92090 |
| Product | Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices. |
| Product code | MGB |
| Recalling firm | TELEFLEX LLC |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P990037 |
| FEI number | 3005747797 |
At a glance
- None 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