Device recall
Z-1837-2022: Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part…
FDA device recall · Class II · Cook Incorporated
Key facts
| Recall number (Z-number) | Z-1837-2022 |
|---|---|
| Recall event | 90793 |
| Product | Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542 |
| Product code | OCY |
| Recalling firm | Cook Incorporated |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K082536 |
| FEI number | 1820334 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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