Device 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
Z-0949-2017
Product summary
- Event
- Event 75999
- Status
- Terminated
- Classification
- Class II
- Quantity
- 335
- Official record key
device-enforcement:Z-0949-2017
Official wording
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.
Code information: Lots: H1014678, H1039272, H1029150, H1039269, H1029151
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.