Events

ARCTICGEL Pads (used with the Arctic Sun Temperature Management System) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bard 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-2016-RN-00234-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00234-1
  • 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
    Bard medical division (bmd) has received complaint reports of low flows associated with certain lots of the arcticgel pads. the clinical risk associated with the restricted/low flow arcticgel pads is suboptimal therapy delivery. in the event that one or more arcticgel pads do not have sufficient flow, the arcticgel pads may need to be exchanged. this may result in a slight delay in the therapy delivery which, if done in a timely manner, is not associated with long-term or residual clinical consequences. if alternate pads are not available, the patient may require therapy delivery by alternate means.
  • 조치
    Bard is advising users to inspect stock for the affected lot numbers. Any remaining affected product can be returned. This action has been closed-out on 30/01/2017.

Device

ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)
  • 모델명 / 제조번호(시리얼번호)
    ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)Multiple Product Codes and Lot Numbers affectedARTG Number: 262560
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd