Events

NeoMed Enteral Feeding Tubes with EO Connectors 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo 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-2018-RN-00734-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-06-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00734-1
  • 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
    Emergo have identified the potential for the tethered plug on the hub inadvertently opening after closure. the tethered plug not staying closed in the feeding tube hub may result in a leak of nutrition from the feeding tube. as described in the instructions for use (ifu) provided with the product, sterile water should be the only liquid that would leak from the feeding tube when the user flushes the tube before and after use. to date, no adverse events related to this issue have been reported to neomed.
  • 조치
    Emergo is requesting that users examine their inventory for product subject to this recall and quarantine all affecetd stock until a return can be facilitated as per the instructions given in the Customer Letter.

Device

NeoMed Enteral Feeding Tubes with EO Connectors

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia