Covidien

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  13A0084N 13A0094 13B0364 13C0514
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide and the country of Bermuda
  • 제품 설명
    Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill || Product ID: 8881570121 || Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Covidien LLC, 15 Hampshire Street, Mansfield MA 02048-1113
  • 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

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