Device recall
Z-1363-2022: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO.035" Delivery System…
FDA device recall · Class II · Cordis US Corp
Key facts
| Recall number (Z-number) | Z-1363-2022 |
|---|---|
| Recall event | 90253 |
| Product | PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX. |
| Product code | FGE |
| Recalling firm | Cordis US Corp |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K033394 |
| FEI number | 1016427 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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