Events

Device Recall PORTACATH 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical ASD 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
    79429
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1073-2018
  • 사례 시작날짜
    2017-12-04
  • 사례 출판 날짜
    2018-03-15
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162307
  • 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
    Certain models and lots of port a cath implantable port kits may have been misassembled. the kits may incorrectly contain a 6fr or 6.5fr size introducer instead of the correct 8.5fr size introducer. the power port a cath ii kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.
  • 조치
    Customers were notified via letter on about 12/04/2017. Instructions include to examine current inventory for affected product, collect and isolate any potentially affected product, determine the total number of potentially affected product in possession and complete and return the Urgent Medical Device Recall Response Form, return any affected product on hand, and notify customers if the affected products were further distributed.

Device

Device Recall PORTACATH
  • 모델명 / 제조번호(시리얼번호)
    a. Item No. 21-4071-24 (Lot No. 86X046, 87X050);  b. Item No. 21-8066-24 (Lot No. 87X178);  c. Item No. 21-8068-24 (Lot No. 87X179)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
  • 제품 설명
    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: || a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); || b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); || c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • 제조사 주소
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • 제조사 모회사 (2017)
    Smiths Group Plc
  • Source
    USFDA