Events

PF6 Tube Assembly (a component of the Peripheral Vascular Infusion/Aspiration Catheter or “PAD” catheter) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Allegra Orthopaedics Limited 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-00493-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00493-1
  • 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
    Allegra orthopaedics is performing a recall of specific lot numbers of the pf6 tube assembly which is a component of the peripheral vascular infusion/aspiration catheter or “pad” catheter. this is the only component of the pad affected by this recall action as this is the component that is ethylene oxide sterilised.Following a review of the validation of the ethylene oxide sterilisation process for the pf6 tube assembly, it was apparent that there is insufficient evidence to demonstrate that a sterility assurance level (sal) of at least 10-6 was achieved.
  • 조치
    Allegra Orthopaedics is advising users to inspect stock and quarantine any remaining units of the affected devices for return.

Device

PF6 Tube Assembly (a component of the Peripheral Vascular Infusion/Aspiration Catheter or “PAD” c...
  • 모델명 / 제조번호(시리얼번호)
    PF6 Tube Assembly (a component of the Peripheral Vascular Infusion/Aspiration Catheter or “PAD” catheter)Catalogue Number: 20-000965Lot Number: 15012700Expiry Date: April 2017ARTG Number: 164450
  • Manufacturer
    Allegra Orthopaedics Limited

Manufacturer

Allegra Orthopaedics Limited