FDA Device recall Z-3190-2024
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) by Merit Medical Systems, citing 7F sheath introducers labeled as 7.5F.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3190-2024 |
| 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
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Reason
7F sheath introducers labeled as 7.5F
Identifiers
| code_info | REF/UDI-DI/Lot (Expiration Date): PSI-7F-11-038 Version F/00884450708835/H2874685 (09-Mar-2027), H2878374 (26-FEB-2027), H2904232 (11-MAY-2027) |
|---|
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-3190-2024%22
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