Drug recall
Custom Procedure Kit, REF: K12T-11077
FDA recall event 95234 · Class II · Merit Medical Systems, Inc.
Key facts
| Event ID | 95234 |
|---|---|
| Recall numbers | Z-3190-2024, Z-3191-2024 |
| Recalling firm | Merit Medical Systems, Inc. |
| Product type | Devices |
| Products | Custom Procedure Kit, REF: K12T-11077, Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 7F sheath introducers labeled as 7.5F |
| Initiation date | Aug 12, 2024 |
| Report date | Oct 2, 2024 |
| City | South Jordan |
| State | UT |
| Country | United States |
| FEI number | 1721504 |
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: