Events

Caliber Inflation Device 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-2017-RN-00758-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00758-1
  • 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, perouse medical has identified that specific product code / lot number combinations of the caliber inflation device may be at risk of containing a crack in the primary packaging, resulting in a breach of the sterile barrier. for a cracked package, there is the risk of microbial contamination (infection) caused by the use of a product. sterility would not be preserved due to a primary packaging damage.
  • 조치
    Bard is advising users to immediately examine their inventory, and quarantine and remove product subject to this recall from their shelves. Do not use or further distribute any affected product. Product is to be returned by either handing to the user's Bard Territory Manager or by contacting Bard Australia Customer Service who will arrange for the return of any affected product.

Device

Caliber Inflation Device
  • 모델명 / 제조번호(시리얼번호)
    Caliber Inflation DeviceProduct Code: CL3030Lot Numbers: 15045606, 15055430, 15065858, 15075121, 15075411, 15075821 and 15085378ARTG Number: 174371
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd