Events

Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Integra Neurosciences 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-2016-RN-01139-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01139-1
  • 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 manufacturer has identified that there is a possibility of an incomplete seal of the product packaging in one specific lot of the ventricular catheter accessory kit. the packaging defect can impact both the inner and outer seals of the product resulting in the possibility that the sterility assurance may be compromised. to date, there have been no complaints submitted and no adverse events reported due to a compromised seal.
  • 조치
    Integra is advising users to inspect inventory and quarantine any remaining units of the affected stock. Affected product will be replaced with unaffected stock. This action has been closed-out on 16/02/2017.

Device

Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)
  • 모델명 / 제조번호(시리얼번호)
    Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)Catalogue Number: 951303Lot Number: 0195786ARTG Number: 172182
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd