Events

Device Recall Lumen Biomedical Xtract Aspiration Catheter system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Volcano 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
    57282
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0445-2011
  • 사례 시작날짜
    2010-11-03
  • 사례 출판 날짜
    2010-11-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95738
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    intravascular catheter - Product Code OGX
  • 원인
    Potential for product failure. packaging/storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury.
  • 조치
    Firm initiated recall on 11/03/2010, and sent notifications to its consignees via letter. The firm has requested that consignees provide the notification to all personnel within the organization and letters will be sent directly to known customers on 11/04/2010 by Volcano. Customers have been instructed to cease use and contact customer service to arrange returns, and credit will be issued.

Device

Device Recall Lumen Biomedical Xtract Aspiration Catheter system
  • 모델명 / 제조번호(시리얼번호)
    Part number 1450-001 size 4.2F and 1451-003 size 5.8F, all lots.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 유통
    Worldwide distribution: USA, Greece, Egypt, Kuwait, Netherlands, Saudi Arabia, Italy, France, Sweden, Portugal, Great Britain, Austria, Switzerland, Germany, Romania, Poland, and Bulgaria
  • 제품 설명
    Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001 size 4.2F, and part number 1451-003 size 5.8F, distributed by Volcano Corporation.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • 제조사 주소
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA