Events

VASOVIEW 4 Endoscopic Vessel Harvesting System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CTS, Inc. dba Guidant Cardiac Surgery 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
    49550
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0476-2009
  • 사례 시작날짜
    2008-09-09
  • 사례 출판 날짜
    2008-12-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73793
  • 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
    Endoscope and accessories - Product Code GCJ
  • 원인
    Packaging unsealed: sterility of product may be compromised due to packaging issue. for further information, please contact the firm at 408-635-6874.
  • 조치
    The firm issued a letter entitled "URGENT FIELD ACTION - IMMEDIATE ACTION REQUIRED *** VASOVIEW(TM) 4 Endoscopic Vessel Harvesting System (Kit Only)" via federal express to its consignees on September 9, 2008. The firm has asked its consignees to return the product. Follow-up calls were made to ensure recall effectiveness.

Device

VASOVIEW 4 Endoscopic Vessel Harvesting System
  • 모델명 / 제조번호(시리얼번호)
    model numbers VH-10242, lot numbers 7100172 to 8081371, and VH-10243, lot numbers 7100171 to 8081271.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and country of Australia.
  • 제품 설명
    VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.
  • Manufacturer
    CTS, Inc. dba Guidant Cardiac Surgery

Manufacturer

CTS, Inc. dba Guidant Cardiac Surgery
  • 제조사 주소
    CTS, Inc. dba Guidant Cardiac Surgery, 170 Baytech Dr, San Jose CA 95134-2302
  • Source
    USFDA