Events

Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra-Raz Ligature Carrier 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook Australia 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-00539-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00539-1
  • 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
    The reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance.There have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices.
  • 조치
    Users are requested to: 1. Review the list provided in the customer letter and examine inventory immediately to identify; and quarantine any affected products. 2. Complete and return the Acknowledgement and Receipt form provided as soon as possible. Users are further advised that supply of these products will be discontinued in Australia.

Device

Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra...
  • 모델명 / 제조번호(시리얼번호)
    Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra-Raz Ligature Carrier Catalogue Identifier: 090002All LotsStamey NeedleCatalogue Identifier: 095030, 095015 and 095000All LotsClarke-Reich Laparoscopic Knot PusherCatalogue Identifier: J-CRKP-042900All LotsARTG Numbers: 212233 and 166926
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd