Events

Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpieces to the RF generator for electrosurgical procedures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Cynosure 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-2016-RN-01267-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01267-1
  • 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
    Cynosure has identified an error in the expiration date on the label of the minor surgery bipolar cable pouch. the expiration date on the individual pouches that are provided in the 5 pack boxes does not match the expiration date on the box. the expiration date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. if the cable is used after that date, sterility may be compromised.
  • 조치
    Customers are advised to return any affected cables that they hold. Cynosure will be replacing affected cables upon receipt of the returned cables. This action has been closed-out on 12/05/2017.

Device

Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpiece...
  • 모델명 / 제조번호(시리얼번호)
    Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpieces to the RF generator for electrosurgical procedures)Affected Lot numbers on package: 50858, 50382, 48543, 50704Affected Lot numbers on BC: 45572,48543 ARTG Number: 274615
  • Manufacturer
    Cynosure Pty Ltd

Manufacturer

Cynosure Pty Ltd