Events

Various Vital-Port Vascular Access SystemsVital-Port Vascular Access Systems, Titanium Power Injectable, Single-Chamber SystemsVital-Port Vascular Access System, Standard, Petite and Mini, Titanium and MRI, Single-Chamber SystemsVital-Port Vascular Access System, Standard and Petite Titanium, Dual-Chamber Systems 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-2017-RN-01453-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-11-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01453-1
  • 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 testing of the non-coring needle, cook medical have identified that the non-coring needle provided with the cook vital-port vascular assess system (vital-port) may cut or dislodge a core or sliver of material from the vital-port septum when the non-coring needle is inserted into the vital-port. this needle is used on the initial implant of the vital-port. vital-port products that have been successfully placed in patients are not impacted by this recall. there have been no adverse event reports from septum leakage or a silicone sliver pushed into the patient associated with these products to date.
  • 조치
    Cook Medical is advising users to inspect stock and quarantine any remaining units of the affected products for return.

Device

Various Vital-Port Vascular Access SystemsVital-Port Vascular Access Systems, Titanium Power Inje...
  • 모델명 / 제조번호(시리얼번호)
    Various Vital-Port Vascular Access SystemsVital-Port Vascular Access Systems, Titanium Power Injectable, Single-Chamber SystemsVital-Port Vascular Access System, Standard, Petite and Mini, Titanium and MRI, Single-Chamber SystemsVital-Port Vascular Access System, Standard and Petite Titanium, Dual-Chamber SystemsMultiple catalogue numbers affectedAll lots are affectedARTG Numbers: 142612, 161948, 145710, 142851
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd