Events

PCA Empty Sterile vials with injector. (Intravenous fluid container). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hospira Pty Limited 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-2012-RN-00800-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-08-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00800-3
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
  • 원인
    There have been reports of leaking injectors on the empty sterile vial. hospira's investigation concluded that injectors had a manufacturing defect in the promixal 'adhesive well' area due to a weak adhesive bond. the injectors accompanying the empty sterile vials may have an increased risk of leaking, particularly during the filling process.
  • 조치
    The sponsor is providing work around instructions to mitigate the risk.

Device

PCA Empty Sterile vials with injector. (Intravenous fluid container).
  • 모델명 / 제조번호(시리얼번호)
    PCA Empty Sterile vials with injector. (Intravenous fluid container).List Number: 060210403ARTG number: 166111
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    DHTGA