Device Recall INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 LivaNova USA 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
    79863
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1918-2018
  • 사례 시작날짜
    2018-03-13
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • 원인
    Some integrated sterile inspire family products contain an incorrect expiration date printed in the unique device identification (udi) bar code and readable code just beneath the barcode. specifically, the expiration date is reported as ddmmyy instead of yymmdd. the expiration date in the applicable field on the package labels are correct as printed.
  • 조치
    On March 13, 2018, notification letters were emailed. Customers were instructed to return response forms, which indicated the following: amount of unused product, and whether they would contact the firm to relabel effected products or if they preferred to be trained on the relabeling procedure. If product was further distributed, customers were instructed to send the notification letter to these additional customers within 2 business days. No action is required for product already used since it was consumed prior to the true expiration date. For further questions, please call (281) 228-7260.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot: 1709190228, UDI: (01)08033178112352(17)200917(10)1709190228, Exp: 09/17/2020
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : NJ, CA, MN, MO, MA
  • 제품 설명
    Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 || The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less
  • Manufacturer

Manufacturer

  • 제조사 주소
    LivaNova USA, 14401 W 65th Way, Arvada CO 80004-3503
  • 제조사 모회사 (2017)
  • Source
    USFDA