FDA Device recall Z-3191-2024
Custom Procedure Kit, REF: K12T-11077
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Custom Procedure Kit, REF: K12T-11077 by Merit Medical Systems, citing 7F sheath introducers labeled as 7.5F.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3191-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-12 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Custom Procedure Kit, REF: K12T-11077
Reason
7F sheath introducers labeled as 7.5F
Identifiers
| code_info | REF/UDI-DI/Lot (Expiration Date): K12T-11077/00884450457863/T2908313 (01-DEC-2024) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3191-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.