Device recall
Z-1827-2022: Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire…
FDA device recall · Class II · Cook Incorporated
Key facts
| Recall number (Z-number) | Z-1827-2022 |
|---|---|
| Recall event | 90793 |
| Product | Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095) |
| Product code | DQX |
| Recalling firm | Cook Incorporated |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171764 |
| FEI number | 1820334 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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