Events

Milestone Wand STA Hand Piece model STA-5050-305 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Henry Schein Halas 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-00578-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-07-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00578-1
  • 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
    Wand hand piece model wa-2050-305 was packaged (pouched) and boxed as a wand sta hand piece model sta-5050-305. although the function of the hand pieces are identical, these hand pieces are used in two different instruments and they will only attach into the correct instrument.
  • 조치
    Milestone is requesting the customers to inspect the inventory of the Wand Handpieces by looking at the cartridge holder locking tab without opening the sterile pouch. If any mislabelled handpieces are identified, Milestone is requesting the customers to contact Milestone Customer Service to obtain return authorisation and / or replacement of the handpieces. Milestone is also instructing the customers that they can also return the entire quantity of the affected STA Handpieces. This action has been closed-out on 31/08/2016.

Device

Milestone Wand STA Hand Piece model STA-5050-305
  • 모델명 / 제조번호(시리얼번호)
    Milestone Wand STA Hand Piece model STA-5050-305 Batch or Lot number:140103Expiry date: January 2019ARTG Number: 95633
  • Manufacturer
    Henry Schein Halas

Manufacturer

Henry Schein Halas