Device Recall IDEAL MAXPAC TOTAL SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    54237
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0868-2010
  • 사례 시작날짜
    2009-12-14
  • 사례 출판 날짜
    2010-02-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-04-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Cardiopulmonary bypass accessory equipment. - Product Code KRI
  • 원인
    Medtronic has identified a small number of autotransfusion one source kits and maxpac/total system lots with incorrect use before dates (ubd) on the outer kit package label. the ubd on the outer label of the kit/pack does not accurately reflect the ubd of the components within the kit/pack. for affected product, the outer label lists a date which may be later than the usb of the components inclu.
  • 조치
    Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" dated December 14, 2009. The letter was addressed to "Valued Customer." The letter described the product and the problem and requested them to quarantine the product and to complete and sign the attached certificate, "Medtronic Recall Certificate (FCA 1002)." For additional information, contact the firm at 763-514-9605.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot #: 1058285, 10059556, 1099512, 1106926, 1106983, 1001369.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    CA, CO, JAPAN, CHINA.
  • 제품 설명
    IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • 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