Events

Device Recall Hemashield Finesse UltraThin Knitted Cardiovascular Patch 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
    57519
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1593-2011
  • 사례 시작날짜
    2010-12-07
  • 사례 출판 날짜
    2011-03-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96450
  • 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
    Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DSY
  • 원인
    One unit of hemashield finesse ultra-thin knitted cardiovascular patch which did not meet the internal release criteria for water permeability was distributed.
  • 조치
    The firm, Maquet, contacted their sole consignee/customer via telephone informing the customer of the recall and instructing the customer to put the unit to the side. On December 8, 2010 a sales representative visited the site to ensure the unit had been put to the side and to ensure the unit was shipped back to Maquet. If you have any questions, call the Manager, Regulator Affairs at 973-709-7487.

Device

Device Recall Hemashield Finesse UltraThin Knitted Cardiovascular Patch
  • 모델명 / 제조번호(시리얼번호)
    510 k - K962342, Product Code/UP #M00202019579P0; Batch #25018564; Exp Date 7/31/2005
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution: SC only.
  • 제품 설명
    Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch || Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
  • 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