Device recall
Z-1612-2024: Route 92 Medical, 070 Access System, REF 1004, Rxonly, Sterile EO. Used for…
FDA device recall · Class I · ROUTE 92 MEDICAL INC
Key facts
| Recall number (Z-number) | Z-1612-2024 |
|---|---|
| Recall event | 94270 |
| Product | Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature. |
| Product code | QJP |
| Recalling firm | ROUTE 92 MEDICAL INC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K203043 |
| FEI number | 3016522967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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