Events

Various Sage Oral Care Products 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-2017-RN-01172-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01172-1
  • 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
    Teleflex medical australia has been advised by the manufacturer sage products llc that there is the potential for cross-contamination of specific oral care solutions manufactured by a third party supplier on equipment shared with non-pharmaceutical products. the affects all oral care products containing solutions manufactured by the third party supplier. the affected products were distributed between july 2015 and august 2017.
  • 조치
    1. Discontinue use and/or further distribution of the affected lots. 2. Immediately quarantine any affected stock and complete the supplied acknowledgement form and email to austcs@teleflex.com 3. Destroy or dispose of affected product and provide records to Teleflex on the supplied acknowledgment form. 4. Complete the supplied recall acknowledgement form and return it to Teleflex. This form must be completed even if you no longer have affected product.

Device

Various Sage Oral Care Products
  • 모델명 / 제조번호(시리얼번호)
    Various Sage Oral Care ProductsMultiple Product Codes and Lot NumbersARTG Numbers: 128439 and 135840
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd