Events

Device Recall EXXCEL Soft Standard Wall EPTFE Vascular Graft 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Cardiovascular, LLC 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
    54355
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0866-2010
  • 사례 시작날짜
    2010-01-20
  • 사례 출판 날짜
    2010-02-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-07-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88312
  • 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
    Vascular Graft Prosthesis (6mm and greater diameter) - Product Code DSY
  • 원인
    Labeling mix up: shelf carton label for exxcel soft thin wall vascular grafts, lot # 12633379 were mislabeled as exxcel soft standard wall grafts. bleeding could occur if wrong product is used.
  • 조치
    Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information.

Device

Device Recall EXXCEL Soft Standard Wall EPTFE Vascular Graft
  • 모델명 / 제조번호(시리얼번호)
    Product Code: M002004910580; Lot # 12633379, Exp: 4/2012
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.
  • 제품 설명
    EXXCEL Soft Standard Wall EPTFE Vascular Graft; || D:8 mm: L: 50 mm straight || Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • 제조사 주소
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA