FDA Device recall Z-0949-2017
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and fac…
- FDA Device
- Class II
- terminated
- Published 2017-01-11
On 2017-01-11 the FDA classified a Class II recall of PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and fac… by Merit Medical Systems, citing recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0949-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-01 |
| Published | 2017-01-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires
Reason
Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.
Identifiers
| code_info | Lots: H1014678, H1039272, H1029150, H1039269, H1029151 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0949-2017%22
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