Device Recall Medtronic Custom Kits

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 0000567714, 0000569193, 0000569453, 0000571627, 0000574238, 0000579154, 0000579157 and 0000580322.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • 제품 설명
    Medtronic One Source Pack Magellan, Catalog Number: COS310. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories. || Medtronic Ideal MAXPAC Total System
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Cardiovascular Revascularization & Surgical Therap, 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 0000574290, 0000574314, 0000574316, 0000580205, 0000608559, 0000618615, 0000640122, 0000640634, 0000771456, 0000772227, 0000777567, 0000780964, 0000781651, 0000800394, 0000920163, 0000739503 and 0000950662.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • 제품 설명
    Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 0000570588, 0000574333, 0000597907, 0000597954, 0000603799, 0000603854, 0000604000, 0000604584, 0000604619, 0000607627, 0000611283, 0000617833, 0000624995, 0000628687, 0000641735, 0000644599, 0000645307, 0000648997, 0000653336, 0000654111, 000065606, 0000662898, 0000666630, 0000666650, 0000676750, 0000680771, 0000682337, 0000697089, 0000699592, 0000708267, 0000708363, 0000712299, 0000721526, 0000727448, 0000738389, 0000756494, 0000762708, 0000797022, 0000805167, 0000805376, 0000806225, 0000806808, 0000812913, 0000838110, 0000846202, 0000849687, 0000850497, 0000854152, 0000854999, 0000856172 and 0000969188.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • 제품 설명
    Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. || Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
  • Manufacturer