Events

Polyurethane Nasogastric Feeding Tube 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 REM Systems 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-2014-RN-00561-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00561-1
  • 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
    The manufacturer, pacific hospital supply company, has determined that in certain lot numbers, after a number of times where routine folding of the tube occurs, the folding site has split which has resulted in leakage from the tube. the stretching during folding can produce a tensile (pulling) force which breaks the bonding between the two surfaces.
  • 조치
    Users are asked to immediately check their facility’s inventory for the affected lot numbers and quarantine any of the affected products. Await instructions from REM SYSTEMS Pty Ltd for the return and replacement of the affected product. This action has been closed-out on 02/02/2016.

Device

Polyurethane Nasogastric Feeding Tube
  • 모델명 / 제조번호(시리얼번호)
    Polyurethane Nasogastric Feeding TubeItem Numbers: PH-05100PU, PH-06100PU, PH-06125PU, PH-08100PU PH-08125PU Lot Numbers : 14004121, 13022911, 14004123, 13022912, 14004125, 13022915, 14004130, 13022913, 14004132 and 13022916 ARTG Number: 204612
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd