Device recall
Z-1830-2022: Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference…
FDA device recall · Class II · Cook Incorporated
Key facts
| Recall number (Z-number) | Z-1830-2022 |
|---|---|
| Recall event | 90793 |
| Product | Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077 |
| 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