Events

Device Recall Heartstring II Proximal Seal/VASOVIEW 6 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
    51242
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0614-2011
  • 사례 시작날짜
    2009-02-05
  • 사례 출판 날짜
    2010-12-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-01-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79407
  • 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
    Laparoscope, general; plastic surgery - Product Code GCJ
  • 원인
    Sterility may be compromised by a loss of package integrity.
  • 조치
    Maquet issued an Urgent Device Removal letter dated February 5, 2009 to customers, explaining the reason for the recall and requesting the product be returned for replacement. Customers were instructed to examine their inventory and discontinue distribution and use of the affected devices. Customers also were requested to complete and return a Field Action Response Form. Maquet can be contacted at 888-880-2874 concerning this recall.

Device

Device Recall Heartstring II Proximal Seal/VASOVIEW 6 Endoscopic Vessel Harvesting System
  • 모델명 / 제조번호(시리얼번호)
    Affected Lot Number Range: 8030373 to 8112071
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution: Nationwide and Internationally.
  • 제품 설명
    Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, || Model Number: VH-2000, || Product is manufactured and distributed by Maquet Corporation || San Jose, CA
  • 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