Events

Sage Comfort impregnated cloth topical skin products(impregnated with barrier creams and/or antiseptic agents & are used to protect &/or clean areas of skin) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Teleflex 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-2016-RN-01128-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01128-1
  • 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 recall was initiated due to product contamination of a few lots of comfort shield barrier cream cloths with the bacteria, burkholderia cepacia, that were manufactured on two production lines. although the contamination has not been identified in any other products, all products manufactured on the same production lines in the relevant period have also been recalled.Topical administration of a product with presence of microbial contamination may cause serious infections in immunocompromised persons and in hospitalised patients, as well as certain other patient groups.
  • 조치
    Teleflex Medical is advising users to inspect stock and quarantine any remaining units of the affected product. Stock can be returned to Teleflex or place of purchase for a credit, refund or replacement. For more details, please see https://www.tga.gov.au/alert/comfort-impregnated-cloth-topical-skin-products . This action has been closed-out on 28/06/2017.

Device

Sage Comfort impregnated cloth topical skin products(impregnated with barrier creams and/or antis...
  • 모델명 / 제조번호(시리얼번호)
    Sage Comfort impregnated cloth topical skin products(impregnated with barrier creams and/or antiseptic agents & are used to protect &/or clean areas of skin)Catalogue Numbers: 7453, 7526, 7905, 7413, 7988, 9601, 9602Various batch numbers affected (see attached)ARTG Number: 227609
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd