Events

Pennine Healthcare Ryles Tubes (used for enteral feeding) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bosco Medical Australia 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-2016-RN-01156-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01156-1
  • 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
    Bosco medical australia pty ltd have been notified by the manufacturer that there is a possibility that a tube could have the print graduations running the wrong way, i.E. they decrease with distance from the tip of the tube, when the correct orientation is that the numbers increase with distance from the tip of the tube. there is the potential for misplacement of the tubes if the print graduations are used as the sole means for confirming the placement of the ryles tube.
  • 조치
    Bosco Medical is advising users to inspect the graduations of the tubes prior to insertion. If affected product is found, replace with unaffected product and contact Bosco for credit or replacement.

Device

Pennine Healthcare Ryles Tubes (used for enteral feeding)
  • 모델명 / 제조번호(시리얼번호)
    Pennine Healthcare Ryles Tubes (used for enteral feeding)Multiple products affected Product Codes: RT-2008/L, RT-2010/L, RT-2012/L, RT-2014/L, RT-2016/L, RT-2018/L, RT-2314, RT-2316All Lot Numbers affectedARTG Number: 144359
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia