Events

CADD Medication Cassette Reservoir, 50ml 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smiths Medical Australasia 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-2015-RN-00081-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00081-1
  • 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
    Smiths medical has received a small number of complaints of leakage associated with the above-referenced cassettes. a small amount of leaking has been found to occur at the welding of the tube to the internal reservoir bag on some cassettes. if the leakage is noticed during cassette filling, it could result in a delay of therapy while an alternative cassette is obtained. if the leakage is noticed during fluid delivery with the patient, it could result in an interruption in therapy while the cassette is replaced.
  • 조치
    End users are requested to inspect their inventory and quarantine the affected Cassettes. A customer service representative will arrange for exchange of any unused affected Cassettes for credit or replacement. This action has been closed-out on 17/08/2016.

Device

CADD Medication Cassette Reservoir, 50ml
  • 모델명 / 제조번호(시리얼번호)
    CADD Medication Cassette Reservoir, 50ml Order Code: 21-7001-24Batch Numbers: 14X297 and 14X323Order Code: 21-7301-24Batch Numbers: 14X324ARTG Number: 145297
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd