FDA Device recall Z-1826-2015
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intende…
- FDA Device
- Class II
- terminated
- Published 2015-07-01
On 2015-07-01 the FDA classified a Class II recall of Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intende… by Merit Medical Systems, citing some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1826-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-04 |
| Published | 2015-07-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Merit Medical Systems |
| Distribution | MA, NE, SC, TN, UT, WI |
Product
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Reason
Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
Identifiers
| code_info | Catalo Number PR0-6F-11-038, Lot Number H767887 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1826-2015%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.