Device Recall PreludeEASE

  • Model / Serial
    Lots: H1014678, H1039272, H1029150, H1039269, H1029151
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • Manufacturer Parent Company (2017)
  • Source
    USFDA