Events

Teflon Tube T2 Humerus, Sterile 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-00438-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00438-1
  • 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
    During a shelf life study, it was found that particular lots of product failed a dye penetration test demonstrating a deficient seam in the sterile packaging. the seams of the pouches made by one supplier were confirmed to be within specification and do not exhibit any non-conformance. the in-house made cross seam was confirmed to be manufactured out of specification. thus these lots have been deemed as having potentially insufficient packaging integrity and therefore regarded to be unsterile.
  • 조치
    Stryker is notifying surgeons of the issue and provided advice on patient follow up. This action has been closed-out on 04/05/2017

Device

Teflon Tube T2 Humerus, Sterile
  • 모델명 / 제조번호(시리얼번호)
    Teflon Tube T2 Humerus, SterileCatalogue Number: 18060073SLot Number: K0432D3ARTG Number: 139623
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA