Events

MediRedi A.V. Fistula Pack (contains the Terumo AVF Set for Haemodialysis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 House With No Steps Hunter Valley Region 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-01168-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01168-1
  • 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
    Kawasumi laboratories inc. in japan has received 4 reports worldwide where the needle cannula of the a.V fistula (avf) set for haemodialysis had separated from the needle hub and remained in the patient’s vein when attempting to remove the needle following the completion of the dialysis treatment. although the possibility of occurrence for such an event is extremely low, there is potential that blood leakage could occur should the needle cannula separate from the hub and remain in the patient’s vein.There have been no reports of patient injury as a result of this issue.
  • 조치
    House with No Steps is advising users to quarantine and destroy any affected stock. This action has been closed-out on 29/08/2016.

Device

MediRedi A.V. Fistula Pack (contains the Terumo AVF Set for Haemodialysis)
  • 모델명 / 제조번호(시리얼번호)
    MediRedi A.V. Fistula Pack (contains the Terumo AVF Set for Haemodialysis)Product Code: FG00605 (SAP 114827)Batch Numbers: 1503091,1504158, 1505197, 1506221, 1507275, 1508296, 1508328, 1509369 Product Code: FG00620 (SAP 114539) Batch Numbers: 1503099, 1505195, 1506231, 1507263, 1508293, 1509348, 1510389Fistula Pack contains the affected Terumo AVF Set for Haemodialysis - AVFE1525CLFG Lot Numbers: 140714I8, 141014I5, 141110I1, 150128I7, 150511I1 ARTG Number: 167750
  • Manufacturer
    House With No Steps Hunter Valley Region

Manufacturer

House With No Steps Hunter Valley Region
  • Source
    DHTGA