Events

Frenenuis Sleep safe Set 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Fresenius Medical Care Deutschland GmbH 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
    20985
  • 사례 시작날짜
    2016-12-23
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Fresenius Medical Care Australia Pty Ltd (NZ), 60 Pavillion Drive, Airport Oaks, AUCKLAND
  • 원인
    The manufacturer has become aware of leakages caused by overwelded coils on the patient and the drainage lines. overwelded coils can lead to difficulties in unrolling the patient and drainage line and can result in rupturing the lines with pinholes and thus leakages may occur.
  • 조치
    Product to be exchanged

Device

Frenenuis Sleep safe Set
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: 5016921 sleeposafe Set, 5016931 sleeposafe Set Plus, 5017391 sleeposafe Set Paed
  • Manufacturer
    Fresenius Medical Care Deutschland GmbH

Manufacturer

Fresenius Medical Care Deutschland GmbH