Events

Feather Touch Vinyl Examination Gloves 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Pro-Pac Packaging Aust 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-2016-RN-01292-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01292-1
  • 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
    It has been found that feather touch vinyl examination gloves are not suitable for medical/biological applications because they do not provide an effective barrier suitable for medical or biological protection.
  • 조치
    Pro-Pac Packaging is advising retailers and distributors to immediately quarantine all Feather Touch Vinyl Examination Gloves with ARTG # 160255 printed on the box, and to contact Pro-Pac who will arrange for the stock to be recovered and replacement stock, or a credit note to be issued. This action has been closed-out on 18/05/2017.

Device

Feather Touch Vinyl Examination Gloves
  • 모델명 / 제조번호(시리얼번호)
    Feather Touch Vinyl Examination GlovesAll sizes and batch numbersARTG Number: 160255
  • Manufacturer
    Pro-Pac Packaging Aust Pty Ltd

Manufacturer

Pro-Pac Packaging Aust Pty Ltd
  • Source
    DHTGA