Events

Device Recall AccuChek 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Disetronic Medical Systems, 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
    34905
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1132-06
  • 사례 시작날짜
    2006-03-31
  • 사례 출판 날짜
    2006-07-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-11-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45363
  • 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
    Infusion set - Product Code LZG
  • 원인
    The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia.
  • 조치
    "U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.

Device

Device Recall AccuChek
  • 모델명 / 제조번호(시리얼번호)
    Lots 5A115UF, 5A164UF, 5B107UF, 5C163UF, 5C235UF, 5D071UF, 5E237UF, 5F249UF, 5G130UF, 5H090UF, 5H232UF, 5I227UF, 5J221UF, 5L115UF and 6A025UF.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
  • 제품 설명
    Accu-Chek FlexLink 1 infusion set; 10/60; Ref number 04540875001. (Distributed outside of the U.S. only).
  • Manufacturer
    Disetronic Medical Systems, Inc.

Manufacturer

Disetronic Medical Systems, Inc.
  • 제조사 주소
    Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
  • Source
    USFDA