Events

OM040R - Doyen-Collin Mouth Gag 120mm Produced between Feb 2016 and Oct 2017 inclusive 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 B Braun 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-2018-RN-00124-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-03-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00124-1
  • 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
    Braun has been notified by the manufacturer that an error in the initial manufacture of these items has been identified resulting in a potential for the protective sleeves to become “sticky” after reprocessing.It has been determined that the used plastic sleeves of the instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing.
  • 조치
    B Braun is advising users to ensure that the affected products are no longer used and to complete and fax the Facsimile Reply Form provided with the Customer Letter to them so that they may arrange for devices to be collected and repaired.

Device

OM040R - Doyen-Collin Mouth Gag 120mm Produced between Feb 2016 and Oct 2017 inclusive
  • 모델명 / 제조번호(시리얼번호)
    OM040R - Doyen-Collin Mouth Gag 120mmProduced between Feb 2016 and Oct 2017 inclusiveARTG Number: 99164
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd