Events

ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece Sheaths 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ConMed Linvatec 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-2017-RN-00293-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00293-1
  • 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
    Conmed has identified that accessory packages contained within the hyfrecator 2000 carton were packaged in error by the manufacturer, with non-sterile handpiece sheaths (ref. 7-796-19) packaged in pouches that were labelled “sterile”. this could cause an end user to use a non-sterile sheath as if it were sterile. conmed has not received any reports that this mislabelling has resulted in injury or illness. only sheaths supplied in the original accessory package of affected hyfrecator cartons are mis-labelled.
  • 조치
    ConMed is advising customers who have an affected Hyfrecator 2000 still in its original sealed carton (unopened) to return the product to ConMed for replacement. Customers who have an out-of-carton (opened) Hyfrecator 2000 are to check if they have any remaining sheaths (Ref. 70796-19) of the affected lots and to return unused affected sheaths for replacement.

Device

ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece Sheaths
  • 모델명 / 제조번호(시리얼번호)
    ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece SheathsConMed Hyfrecator 2000 Electrosurgical UnitReference Number: 7-900-230Multiple Serial NumbersAccessory Package containing Handpiece SheathsReference Number: 7-796-19 Lot Numbers: 201511234, 201512074, 201512094, 201601064, 201603284ARTG Number: 130647
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd