Events

300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 KCI Medical Australia 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-01169-1
  • 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-01169-1
  • 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
    Internal testing has revealed the potential for small holes the size of a pin to develop in the pouches of the sterile canisters. if these small holes occur and the canister is used in a sterile field, there is a potential for contamination.To date, there have been no complaints regarding damaged packaging or reports of any patient injuries or complications due to potentially non-sterile canisters.
  • 조치
    The sponsor is advising the users to inspect stock and quarantine the affected units prior to their return. Alternatively, users can continue to use the affected devices provided that the tubing cap remains in the tubing until use and the canister is used outside of the operating room's sterile field. This action has been closed-out on 26/08/2016.

Device

300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System
  • 모델명 / 제조번호(시리얼번호)
    300mL Canister (with Gel) for use with the ActiV.A.C. Therapy System Part number M8275059/5Lot Numbers: 2590876 (expiry date 11/2016) and 2590877 (expiry date 01/2017) ARTG Number: 226774
  • Manufacturer
    KCI Medical Australia Pty Ltd

Manufacturer

KCI Medical Australia Pty Ltd