Events

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-01089-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01089-1
  • 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
    Lemaitre embolectomy catheters are indicated for the removal of arterial emboli and thrombi. a small number of these products from the affected lot may have a compromised sterile barrier due to a packaging tube defect in the form of a pinhole at the sealed end of the packaging tube. the current ifu does not require inspection of the packaging prior to use and loss of product sterility could not be visually identified. the issue occurred due to fluctuations in the power sources for the sealing machine during the packaging tube manufacturing process.Loss of product sterility could lead to cross-contamination and infection.No complaints have been received relating to this issue.
  • 조치
    Users are asked to inspect their stock and quarantine all affected units prior to their return to Emergo as per the instructions in the Customer Letter. This action has been closed-out on 18/08/2016.

Device

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia