Events

Device Recall PowerPort Slim Implantable Port 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Access 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
    67567
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1300-2014
  • 사례 시작날짜
    2014-02-27
  • 사례 출판 날짜
    2014-03-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125727
  • 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
    Intravascular, subcutaneous implanted catheter - Product Code LJT
  • 원인
    Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a powerport slim titanium implantable port without silicone suture plugs.
  • 조치
    Notified by Urgent Customer Notification Letter date February 13, 2014, customers were asked to immediately examine their inventory and identify any product subject to this notification. In addition, if they have further distributed this product, please identify customers and notify them at once of this notification. Customers may include a copy of this letter in your notification to customers. Customers may choose to use the involved product with the understanding that the kit may contain a PowerPort¿ Slim implantable port without suture plugs, or may return the applicable product for replacement or credit.

Device

Device Recall PowerPort Slim Implantable Port
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: REXA1302, REXA1350, REXB1160
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide distribution including WA, KY, IL, and IA.
  • 제품 설명
    PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • 제조사 주소
    Bard Access Systems, 605 North 5600 West, Salt Lake City UT 84116-3738
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA