Events

TOPPER Xtra Absorbent Dressing Pads, Sterile 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 KCI Medical 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-2014-RN-00893-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00893-1
  • 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, systagenix has become aware that the sterility of some product may be compromised due to small holes in the bottom layer of the primary pouch; its subsequent use may therefore pose a potential risk of localised infection.
  • 조치
    Users are advised to discontinue use of affected stock and monitor any patients who are using, or have recently used, any of the affected products for signs of localised infection, including heat, pain, redness or swelling around the wound or increased wound drainage. If symptoms are presented then the clinician should treat appropriately. This action has been closed-out on 1/06/2016.

Device

TOPPER Xtra Absorbent Dressing Pads, Sterile
  • 모델명 / 제조번호(시리얼번호)
    TOPPER Xtra Absorbent Dressing Pads, Sterile Product codes: P55263 and P55264 – all pack sizesAll lots affectedARTG number: 168750
  • Manufacturer
    KCI Medical Australia Pty Ltd

Manufacturer

KCI Medical Australia Pty Ltd