Events

Device Recall TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER 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
    55175
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1525-2010
  • 사례 시작날짜
    2010-03-18
  • 사례 출판 날짜
    2010-04-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90222
  • 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
    8f powerport stems were mixed with 6f powerports and packaged.
  • 조치
    The firm, Bard Access Systems, Inc. (BAS) sent a "URGENT: Powerport isp M.R.I with 6F Chronoflex Catheter RECALL" letter dated March 18, 2010, to the customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to immediately examine their inventory and quarantine all products subject to this recall and notify any customers they may have distributed the product to; DO NOT USE THIS PRODUCT OR FURTHER DISTRIBUTE ANY OF THE IMPLICATED LOTS; remove and return the affected lots to BAS, and complete and Fax the Reply Form and Inventory Reconciliation Form, if unable to Fax call and report information. Only unused products, in its original packaging, should be returned to BAS. Should you have any questions or require assistance in this matter, please contact BAS Customer Service by calling our toll-free number 1-800-290-1689.

Device

Device Recall TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
  • 모델명 / 제조번호(시리얼번호)
    REF#1806061 2 lots: Lot # RETE0854 and RETG1016
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC.
  • 제품 설명
    PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico || Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.
  • 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