Device recall
Z-0649-2023: DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
FDA device recall · Class II · DeRoyal Industries Inc
Key facts
| Recall number (Z-number) | Z-0649-2023 |
|---|---|
| Recall event | 91134 |
| Product | DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03 |
| Product code | LRO |
| Recalling firm | DeRoyal Industries Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1043214 |
At a glance
- None Linked 510(k)s
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