Device recall
Z-1829-2022: Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN…
FDA device recall · Class II · Cook Incorporated
Key facts
| Recall number (Z-number) | Z-1829-2022 |
|---|---|
| Recall event | 90793 |
| Product | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427 |
| Product code | DQX |
| Recalling firm | Cook Incorporated |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171997 |
| 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