Ultrasound Probe Cover (Telescopic folded with gel); and All Products labelled Meditech and Manufactured by: Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Meditech Systems Asia Pacific 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-2017-RN-00631-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-05-12
  • 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
    Meditech systems asia pacific has become aware that the product ultrasound probe cover (telescopic folded with gel) may be contaminated with burkholderia cenocepacia. whilst no other batches or pack sizes of this product have been supplied by meditech, users are further advised that all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd.Are also affected by this recall.
  • 조치
    All product labelled Meditech and Manufactured by Yafho Bio-Technology Co Ltd and/or Linmed Medical Co Ltd, including all stock of UltraSound Probe Cover (Telescopic folded with gel), is being quarantined immediately and Recalled from the Market. For further information please see https://www.tga.gov.au/alert/meditech-ultrasound-gel .

Device

  • 모델명 / 제조번호(시리얼번호)
    Ultrasound Probe Cover (Telescopic folded with gel); andAll Products labelled Meditech and Manufactured by: Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd.Part Number/ Order Code: 88654012Lot Number: 201701ARTG Number: 278197
  • Manufacturer

Manufacturer