Device Recall DLP Antegrade/Retrograde Adapter

  • 모델명 / 제조번호(시리얼번호)
    Model No. 13001; Product UPN 20613994677611; Lot No. 2016020795, 2016030222, 2016030813, 2016031019, 2016040411, 2016040614, 201604C004, 2016050516, 2016050769, 2016051176, 2016060227, 2016061042, 2016061440, 2016070193, 2016070921, 2016070922, 2016080373, 2016090545, 2016091365, 2016100614, 2016101189, 2016101190, 2016110125, 2016110825, 2016111024, 2016111026, 201612C046, 2017010914, 2017010915, 2017020855, 2017020856, 2017021022, 201702C012, 2017030536, 2017031116, 2017040101.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.
  • 제품 설명
    DLP Antegrade/Retrograde Adapter || Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA