Device Recall ReSolve

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
  • 제품 설명
    Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot No: E796578 E796579  MR792035 MR786325  MR797946  MR791206  MR791212 MR786923  E796605 MR786311  MR791660 E796647 RL MR795466  MR786301  E796629 E796631 E796636 E796637 MR786306 MR786320 MR786318  MR786319
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the Virgin Islands.
  • 제품 설명
    ReSolve Locking Drainage Catheters || The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 08032014
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.
  • 제품 설명
    ReSolve Halo - Open Back Halo Ring, Model Number: 505300D || The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 08033120, 08040201, 08050204, 08051414, 08060514, 08070706, 08080710, 08091521, 08093027, and 08102723.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.
  • 제품 설명
    ReSolve Halo - Open Back Halo Ring, Model Number: 505400D || The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot #: 08052718
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.
  • 제품 설명
    ReSolve Halo - Open Back Halo Ring, Model Number: 510400D || The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
  • Manufacturer