Device Recall Medtronic Carmedacoated

  • 모델명 / 제조번호(시리얼번호)
    Catalog / Lot: CB96345-023 / 9890956, CB96345-023 / 9890955, CB96345-029 / 9866550
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • 제품 설명
    Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numbers: CB96345-023, CB96345-023, and CB96345-029.
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 11 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Catalog / Lot: 71166 / 9821992, 71166 / 9826735.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • 제품 설명
    Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Resistant Fiber. Single Use gas exchange device for Cardiopulmonary Bypass. Catalog Number: 71166
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog / Lot: CB0B90R3 / 9871463, CB0L44R15 / 9904942, CB0X97R10 / 9818263, CB1V99R2 / 9887322, CB1Y06R14 / 9872639, CB1Z42R15 / 9568381, CB1Z69R12 / 9805685, CB1Z69R12 / 9819156, CB1Z85R16 / 9816273, CB2503R1 / 9879856, CB2K59R8 / 9816253, CB2K59R8 / 9819175, CB2S52R4 / 9882568, CB2U05R1 / 9834608, CB2W86R2 / 9812228, CB3E29R5 / 9819173, CB3L87R4 / 9839338, CB3U53R7 / 9894969, CB3X44R4 / 9837298, CB4741R15 / 9823284, CB4E05R6 / 9892093, CB4F32R3 / 9819157, CB4F32R3 / 9819650, CB4F32R3 / 9867648, CB4G10R5 / 9885608, CB4Q81R / 9866753, CB4S04R2 / 9841997, CB4T12R2 / 9861563, CB4W67R3 / 9837302, CB5N65R2 / 9904072, HY1709R34 / 9818265, HY3B29R13 / 9895128, HY4X31R7 / 9864540, HY5C74R15 / 9838652, HY5H32R5 / 9879895, HY5L38R1 / 9859513, HY5L72R1 / 9882604, HY5R03R / 9861103, TL2L66R5 / 9859465
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • 제품 설명
    Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB1Z69R12, CB1Z69R12, CB1Z85R16, CB2503R1, CB2K59R8, CB2K59R8, CB2S52R4, CB2U05R1, CB2W86R2, CB3E29R5, CB3L87R4, CB3U53R7, CB3X44R4, CB4741R15, CB4E05R6, CB4F32R3, CB4F32R3, CB4F32R3, CB4G10R5, CB4Q81R, CB4S04R2, CB4T12R2, CB4W67R3, CB5N65R2, HY1709R34, HY3B29R13, HY4X31R7, HY5C74R15, HY5H32R5, HY5L38R1, HY5L72R1, HY5R03R, and TL2L66R5.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog / Lot: CB4014 / 9827678
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • 제품 설명
    Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Bypass. Catalog Number: CB4014
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog / Lot: CB511 / 9816345, CB5201R14 / 9828465, CB5227R4 / 9879857
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • 제품 설명
    Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog / Lot: CB67532 / 9816217
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • 제품 설명
    Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532
  • Manufacturer
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