Events

Scalpel in Lifemed Procedure Packs 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-2018-RN-00267-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00267-1
  • 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
    Product complaints received by bard australia reported that the safety sheath covering the scalpel blade (component number in1951) was found in a very low number of lifemed procedure packs as being not engaged, resulting in an exposed blade that could inadvertently lead to a cut during manual handling by health care professionals, especially in circumstances where they are unaware of this anomaly whilst opening the pack.This issue does not impact the sterility of the packs.
  • 조치
    Users are being made aware of this issue and asked to take extra care when opening the procedure packs. Affected units may be returned at the discretion of the customer on a case by case basis.

Device

Scalpel in Lifemed Procedure Packs
  • 모델명 / 제조번호(시리얼번호)
    Scalpel in Lifemed Procedure PacksComponent: IN1951Multiple Product Codes and Lot NumbersARTG Numbers: 180554 Bard Australia - Surgical procedure kit, general- purpose, single-use, non-medicated;180555 Bard Australia - Angiographic kit;189114 Bard Australia - Lifemed Angiography Pack with Guidewire - Angiographic kit; and193043 Bard Australia - Surgical procedure kit, general-purpose, single-use, non-medicated
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd