Events

Device Recall Pressure Monitoring Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corporation 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
    58838
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2613-2011
  • 사례 시작날짜
    2011-05-03
  • 사례 출판 날짜
    2011-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100395
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • 원인
    The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. the firm determined that the defect was caused by a change in the pressure dome's manufacturing process.
  • 조치
    Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 3, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were sent 10 replacement pressure monitoring kits with the removal notice as immediate replacements. The firm will send additional replacements to customers that have more than 10 units of affected product as noted on the Customers' returned reponse form. Customers that received the custom packs were provided stickers to identify the recalled packs. The customers were instructed not to open the packs to remove the affected pressure monitoring kit prior to clinical use, but to replace the pressure domes at the time of use. For more information please contact Terumo Cardiovascular Customer Service at 800- 521-2818.

Device

Device Recall Pressure Monitoring Kit
  • 모델명 / 제조번호(시리얼번호)
    0511829, 0519808, 0522673, 0537066, 0538520, 0544571, 0548624, 0552118, 0555878, 0557544, 0563808, 0565139, 0571582, 0575070, 0578021, 0578529, 0579318, 0580173, 0582267, 0584399, 0587165, 0589587, 0592742, 0593799, 0595311, 0595312, 0604098.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide )including the states AR, CA, FL, GA, MO, MT, NC, ND, OK, OR, PA, TN, TX, UT, VA, WA and WY, and the countries of Argentina, Belgium, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatamala, Honduras, Hong Kong, Indonesia, Kuwait, Malaysia, Mexico, Pakistan, Panama, Philippines, Singapore, South Korea, Thailand, United Arab Emirates, Uruguay and Vietnam
  • 제품 설명
    Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA