Events

PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 deg 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smiths Medical Australasia 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-2015-RN-00944-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00944-1
  • 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
    Smiths medical has become aware of a labelling issue with one lot of port-a-cath plastic hub needles. the label on the lid stock of the individual needle package lists the incorrect product reorder number, description and product image. the product reorder number should be 21-2287-24 with a corresponding description and product image, but instead it lists the 21-2005-24 product reorder number, description and product image. the needle inside the individual package is the product reorder no. 21-2287-24 needle and the outer carton label lists the correct reorder number 21-2287-24.
  • 조치
    Smiths Medical is advising customers to quarantine affected stock. Any affected stock will be replaced or a credit issued.

Device

PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 deg
  • 모델명 / 제조번호(시리얼번호)
    PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in) 90 degProduct re-order Number: 21-2287-24Lot Number: 46262ARTG Number: 145298
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd