Events

ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medical Specialties 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-00091-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00091-1
  • 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 (isomed) has advised that for procedures requiring embolectomy/thrombectomy of arteriovenous (av) fistulas, the catheter used should have the tensile strength to withstand at least 9n of resistance. after extensive testing, it was determined that the maximum resistances of the isomed 2f, 3f & 4f single lumen arterial embolectomy catheters are: 3n, 5n & 9n respectively. to minimise the risk of vessel damage, balloon rupture or tip detachment in av fistula procedures, it is recommended that single lumen arterial embolectomy catheters of less than 4f (i.E. 2f & 3f) should not be used for these procedures. the “warnings” section of the ifu has been updated to include this information.
  • 조치
    Medical Specialties Australia is advising users to immediately inspect their stock for affected products. IFUs in the affected stock are to be discarded and replaced with a copy of the updated IFU. This action has been closed-out on 26/05/2017.

Device

ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)
  • 모델명 / 제조번호(시리얼번호)
    ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)Product/Catalogue Numbers (2F): 300240, 300260, 300280, 300240T, 300260T, 300280TProduct/Catalogue Numbers (3F): 300340, 300360, 300380, 300340T, 300360T, 300380TAll Lots/Batches affectedARTG Number: 168959
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA