The ARROWg+ard Blue PLUS antimicrobial catheter 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Teleflex Medical Australia Pty Ltd 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
    RC-2018-RN-00358-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-30
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    It has been identified that certain product may have packaging that is not sealed. in the event the packaging is compromised in this manner, sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for an infection to occur. to date, teleflex medical has not received reports of this issue in australia.
  • 조치
    Teleflex is advising customers to inspect inventory for impacted lots and identify any units that appear to be affected. These units should then be discarded and Teleflex will provide a suitable credit following receipt of the acknowledgement form suppled with the customer letter.

Device

  • 모델명 / 제조번호(시리얼번호)
    The ARROWg+ard Blue PLUS antimicrobial catheterMultiple Lot NumbersARTG Numbers: 138302, 136923, 278735, 278926 and 279697
  • Manufacturer

Manufacturer