Events

Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easier capture using a pipette) 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-2015-RN-00997-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-10-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00997-1
  • 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
    This batch is being recalled as it was formulated with an excess of water, diluting the product outside the design specification. the batch met all of the release specifications, including mouse embryo assay; however, the effect of this dilution is a loss of viscosity, and creation of a hypo-osmotic environment for the sperm. this may make it difficult for the embryologist to capture the sperm, and may lead to swelling of the sperm tail.
  • 조치
    Cook Medical is advising users to any discard remaining stock. Cook Medical will replace affected stock with a credit or replacement. This action has been closed-out on 04/03/2016.

Device

Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easie...
  • 모델명 / 제조번호(시리얼번호)
    Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easier capture using a pipette) Product Code: K-SIPV-200-5 Bulk batch number M0615061ZLot Numbers: K22948, K22752, K22551, K22825, K22625, K23042 ARTG number 132688
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd