Events

General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile) General Laparoscopy Procedure Pack 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medline International Two 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-2016-RN-00882-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00882-1
  • 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
    This letter is to inform users that medline is recalling two procedure packs, the general laparoscopy and the gynecological laparoscopy, as they contain a conmed core suction irrigation handpiece. medline was informed by conmed that the core suction irrigation handpiece may contain creases in the packaging seal which sometimes results in an open channel. these channels may compromise sterility of the product. there have been no reports of injuries as a result of this issue.
  • 조치
    Medline is advising users to check the procedure packs in stock, remove and retain the ConMed CORE suction Irrigation Handpiece for return. Medline will replace the affected handpieces with unaffected stock. This action has been closed-out on 20/01/2017.

Device

General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE ...
  • 모델명 / 제조번호(시리얼번호)
    General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile) General Laparoscopy Procedure PackProduct Codes: CSBABRMQ18A and CSBABRMQ18BGynecological Laparoscopy Procedure Pack Product Codes: CSMABRMQ10A and CSMABRMQ10BARTG Number: 137395
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd