Device Recall 7F Prelude Short Sheath Introducer

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: H1041469, H1041473, H1036880, H1041464.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
  • 제품 설명
    7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. || Produc Usage: || The Merit Prelude¿ Short 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. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • 제조사 모회사 (2017)
  • Source
    USFDA