Drug recall
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
FDA recall event 92608 · Class II · Creganna Medical Devices
Key facts
| Event ID | 92608 |
|---|---|
| Recall numbers | Z-2249-2023 |
| Recalling firm | Creganna Medical Devices |
| Product type | Devices |
| Products | Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Three lots of product may be labeled with an incorrect expiration day |
| Initiation date | Jun 22, 2023 |
| Report date | Aug 9, 2023 |
| City | Galway |
| Country | Ireland |
| FEI number | 3004193842 |
At a glance
- 1–9 Products in this recall
- 1–9 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: