Sonidet – Medical Equipment & Instrument Detergent 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Whiteley Corporation Pty Ltd t/a Whiteley Medical 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-2015-RN-00186-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-06
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Whitely corporation has identified microbial contamination in the sonident liquid detergent. the microorganism was identified as pseudomonas aeruginosa.
  • 조치
    Whitely Corporation is requesting the customers to identify and quarantine all stock. Whiteley Corporation is making arrangements to collect any stock of Sonidet B/N: 49012 for return to their warehouse for a credit. Whitely Corporation is currently in negotiation with the TGA on when new stock can be released to the market. This action has been closed-out on 31/05/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Sonidet – Medical Equipment & Instrument DetergentPack Size: 2 X 5L Dosage Form: Liquid detergentBatch Number: 49012 Expiry Date: December 2016 Stock code: 190377ARTG number: 125529
  • Manufacturer

Manufacturer