Events

Cardioxyl Sutures 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Reid Healthcare 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-00670-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00670-1
  • 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
    A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. the treatment substance which is used during the manufacture for easing the crimping process of the needles is only applied on the area where the thread is in contact with the needle ie, approximately one (1) cm from the end of the thread. the treated ends are clearly out of the implanted section of the thread.
  • 조치
    Customers are advised to inspect their stock and quarantine all affected units. Reid Healthcare Pty Ltd will arrange for affected stock to be recovered and issued with replacement stock or a credit note.

Device

Cardioxyl Sutures
  • 모델명 / 제조번호(시리얼번호)
    Cardioxyl SuturesProduct Numbers: : 73130AN, 73130T, 73P30A, 73P30AM, 73P30AN, 73P30BS, 73P30O, 73P30P, 73P30R, 73P30U, 73P30V, 73S30AE, 73S30AG, 73S30AT, 73S30AX, 73S30P and 73S30VMultiple batch numbersARTG Number: 166050
  • Manufacturer
    Reid Healthcare Pty Ltd

Manufacturer

Reid Healthcare Pty Ltd