Events

Neria Infusion Administration Set 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Clinect 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-00536-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00536-1
  • 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 manufacturer of the product, unomedical a/s has found that in rare cases the steel needle can break during use, interrupting the delivery of medication. if the needle breaks during use, the delivery of medicine will be interrupted and the patient may experience a range of symptoms depending on therapy area and medication used. additionally, if a broken needle remains in the body, it can lead to infection which, in rare cases, might require surgical removal.
  • 조치
    Clinect is notifying patients of the issue and providing instruction to ensure the safe use of the devices, however, should patients wish to return the device this can be arranged through their supplier. Clinect is also recovering potentially affected stock from hospitals, retailers and distributors. This action has been closed-out on 12/08/2016.

Device

Neria Infusion Administration Set
  • 모델명 / 제조번호(시리얼번호)
    Neria Infusion Administration Set Models : G27-6mm-60cm, G27-8mm-80cm, G27-10mm-80cm and Multi 2 G27-8mmRef. numbers: 78-060-2736, 78-080-2738, 78-080-2731 and 721060-2738Lot numbers: 5017071, 5024517, 5033612, 227979, 227980, 5006113, 5006114, 5006115, 5028915, 5063419, 5020514, 5022947, 5033623, 5063787ARTG number: 198459
  • Manufacturer
    Clinect Pty Ltd

Manufacturer

Clinect Pty Ltd