Drug recall
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO.035" Delivery System, Catalog numbers PG2990BPS…
FDA recall event 90253 · Class II · Cordis US Corp
Key facts
| Event ID | 90253 |
|---|---|
| Recall numbers | Z-1363-2022 |
| Recalling firm | Cordis US Corp |
| Product type | Devices |
| Products | PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for stent dislodgement and associated failures related to two specific sizes of the device. |
| Initiation date | May 20, 2022 |
| Report date | Jul 20, 2022 |
| City | Miami Lakes |
| State | FL |
| Country | United States |
| FEI number | 1016427 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: