Events

Aerowound Combine Dressing ACD2040S, size 20cm x 40cm 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Aero Healthcare 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-00283-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00283-1
  • 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 aerowound combine dressing is comprised of an absorbent pad enclosed in a polyester/viscose over bag. each sterile dressing is sealed in an individual pouch. it was discovered that one of the pouch edges has a weak sealing strength which could compromise the sterility of the device.
  • 조치
    Aero Healthcare is advising customers to quarantine all affected stock within their control. Distributors are advised to forward the recall notice to retailers to whom they have sold affected products and to accept the affected stock returned to them. Distributors are further requested to contact Aero Healthcare to organise their return.

Device

Aerowound Combine Dressing ACD2040S, size 20cm x 40cm
  • 모델명 / 제조번호(시리얼번호)
    Aerowound Combine Dressing ACD2040S, size 20cm x 40cmBatch Number: 17110Expiry Date: 31 August 2021ARTG Number: 159437
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare