Events

Lancet, Low Flow and Micro Flow 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Linear Medical 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-00695-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00695-1
  • 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 identified that a small number of low & micro flow lancet needles of the batches listed fail to retract completely within their casing after use. improper handling of the device in these instances poses a risk to the user.
  • 조치
    Linear Medical is requesting their customers to discard any remaining single units of product and return any unopened boxes for replacement.

Device

Lancet, Low Flow and Micro Flow
  • 모델명 / 제조번호(시리얼번호)
    Lancet, Low Flow and Micro FlowLow Flow LancetProduct Code: LLAN10113Batch Number: 010913LAMicro Flow LancetProduct Code: LLAN10213Batch Number: 020913LAARTG Number: 214608
  • Manufacturer
    Linear Medical Pty Ltd

Manufacturer

Linear Medical Pty Ltd