Events

Device Recall Trellis 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bacchus Vascular Inc 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
    27855
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0816-04
  • 사례 시작날짜
    2003-11-24
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-05-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30639
  • 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
    Catheter, Continuous Flush - Product Code KRA
  • 원인
    The device has the potential for fractures at the distal end during use.
  • 조치
    On 11/24/03, all consignees were notified via phone calls and/or on-site visit by the firm''s sales representative, informing them of the affected devices and providing instructions on the recall.

Device

Device Recall Trellis
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: M02-50216, M02-50217, M02-50219, M02-50220, M02-50227, M02-50228, P02-30014, P02-30013
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was released for distribution to 131 consignees in US. The firm identified 18 foreign distributors that received recall products. The product received nationwide distribution. The firm has also distributed products into international channels through distributors. Countries include: NETHERLANDS, Argentina, ISRAEL, Czech Republic, ARGENTINA, GERMANY, AUSTRIA, SWITZERLAND, IRELAND, HONG KONG, GERMANY, GREECE, Belgium, SOUTH AFRICA, UK, ITALY, UK, and NORWAY There is no known U. S. Government or Canadian distribution.
  • 제품 설명
    Bacchus brand Trellis¿ Plus, Peripheral Infusion System, 6.0 Fr || Catalog Numbers: || BAC TRR 006 140 10, || BAC TRR 006 140 20
  • Manufacturer
    Bacchus Vascular Inc

Manufacturer

Bacchus Vascular Inc
  • 제조사 주소
    Bacchus Vascular Inc, 3110 Coronado Dr, Santa Clara CA 95054-3205
  • Source
    USFDA