Unitek Victory Mini Tube Lower Left Buccal TubePack of 5 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 3M 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-2015-RN-00937-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-09-18
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Due to operator error, the labelling for this specific batch is incorrect. the notation on the blister lid shows the contents to be a lower right buccal tube, when the blister actually contains a lower left buccal tube. the catalogue number and batch number are correct and the outer box labelling is correct.There is no risk to the patient. the error is easily recognised by the orthodontist, upon visual inspection prior to use.
  • 조치
    The affeted customer is requested to inspect and quarantine stock on hand prior to arranging a return for either replacement or credit. This action has been closed-out on 18/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Unitek Victory Mini Tube Lower Left Buccal TubePack of 5Catalogue number: 3067-8373 Batch number: GQ9SZ-0005ARTG Number: 99491
  • Manufacturer

Manufacturer