Events

Bard ArcticSun ArticGel Pads 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-00770-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-06-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00770-1
  • 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 confirmed that lot ngar0462 is incorrectly identified as 317-09 (large kit) rather than 317-07 (medium kit) on the product (shelf) box. specifically, the shelf box has a black tick mark in the catalogue marked 317-09 instead of 317-07. the shelf box label with barcode and the pouch label is correctly identified as 317-07 and lot number ngar0462. this mislabelling could potentially result in a slight delay in therapy but is not associated with long term or residual clinical consequences.
  • 조치
    Bard Australia is requesting that following an inspection of stock on hand, customers should cross out the incorrectly marked line and tick the correct box “317-07”. The Recall for Product Correction does not require affected stock to be returned. Affected stock can remain on your shelves.

Device

Bard ArcticSun ArticGel Pads
  • 모델명 / 제조번호(시리얼번호)
    Bard ArcticSun ArticGel PadsProduct Code: 317-07Lot Number: NGAR0462 ARTG Number: 262560
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd