Events

Device Recall Celsite Access Port 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 B. Braun Interventional Systems 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
    52611
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1961-2009
  • 사례 시작날짜
    2009-06-22
  • 사례 출판 날짜
    2009-09-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83457
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • 원인
    B. braun interventional systems was notified by b. braun medical france, the manufacturer of the celsite access port that they had received 11 reports of polyurethane (type p) catheter disconnections. b. braun medical france has decided to recall all celsite¿ ports supplied with the affected catheter lot. to date, b. braun interventional systems (us) has not received any reports of catheter dis.
  • 조치
    B. Braun Interventional Systems, Inc. issued an "Urgent: Medical Device Recall" notice dated June 22, 2009. The letter identified the problem and product. The letter reminded the consignee of the general instruction for use of access ports and instructed them to contact patients who had the Celsite port system implanted. For further questions, contact B. Braun Interventional Systems, Inc. at 1-800-523-9676 extension 4818.

Device

Device Recall Celsite Access Port
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: H3238310 and I0059950.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- NY.
  • 제품 설명
    Celsite Access Port Model ST305P. || The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems.
  • Manufacturer
    B. Braun Interventional Systems

Manufacturer

B. Braun Interventional Systems
  • 제조사 주소
    B. Braun Interventional Systems, 14276 23rd Ave N, Plymouth MN 55447-4910
  • 제조사 모회사 (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA