Versaport Bladeless Optical 5mm Trocar

제조사

  • 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
    SATP

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model: Models: ONMB5LGF ONB5SHF ONB5STF ONB5STF2C ONBFCA5SH ONBFCA5ST, Affected: Lots manufactured since Jan-2012
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Covidien Versaport Bladeless Optical 5mm Trocar with Fixation Cannula
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)Multiple product codes and lot numbers:ONB5LGF (Lots N2K0019X through N3A0294X)ONB5SHF (Lots N2J0265X through N3A0391X)ONB5STF (Lots N2H0353X through N3D0033X)ONB5STF2C (Lots N2J0211X through N3D0118X)ONBFCA5SH (Lots N2J0315X through N3A0389X)ONBFCA5ST (Lots N2J0150X through N3C0683X)ARTG Number: 178557
  • Manufacturer