Events

Salter Labs Oxygen Cannulas 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Wymedical 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-01545-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01545-1
  • 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
    Wymedical has been made aware of an issue with certain salter labs oxygen cannulas. the material used for the canulas are prone to twisting and may inhibit oxygen passage.
  • 조치
    Customers are to complete the supplied acknowledgement form immediately even if they do not have any affected stock and return it to Wymedical. Return affected stock on hand as directed with the completed inventory form to receive RGA number and advise when stock is ready for pick up.

Device

Salter Labs Oxygen Cannulas
  • 모델명 / 제조번호(시리얼번호)
    Salter Labs Oxygen CannulasCatalogue Number: 1615-7 and 1601-7Lot Number: SFT 072417 and Lot Number SFT073117ARTG Number; 168942 (Wymedical Pty Ltd - Cannula, nasal, oxygen)
  • Manufacturer
    Wymedical Pty Ltd

Manufacturer

Wymedical Pty Ltd