Events

Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CareFusion Australia 316 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-2017-RN-00350-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00350-1
  • 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 has received six reports where an open seal of the immediate packaging of devices was identified by customers. this open seal has the potential to compromise the sterility of the device(s). to date, no reports have been received in australia.The packaging for the affected product codes were found to have an opening in the seal which maintains the sterility of the device. the issue of the packaging failure is visually obvious.
  • 조치
    Customers are advised to discontinue use of the identified codes for the affected lot numbers. Contact BD to return and if required arrange a replacement or credit.

Device

Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow
  • 모델명 / 제조번호(시리얼번호)
    Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow Thoracentesis/paracentesis kit 10/CS - TPK1001 Lot No. (LN): 0000851185, 0000840336, 0000842215, 0000837811Illinois (TJ) needle aspiration - TIN3015, TIN3018LN: 0000841213, 0000848061, 0000841215, 0000841212, 0000852078Jamshidi (TJ) needle bone marrow - TJM4011, TJC6011, TJC3513, TJC4011 LN: 0000852932, 0000843076, 0000853878, 0000841124, 0000851431, 0000850937 ARTG: 120894, 120890, 120892
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd