Events

Devon Light Glove 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Covidien 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-00364-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00364-1
  • 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
    Covidien received reports that the light glove may contain splits or holes or be torn. should the user be unaware that the light glove is torn or split, a mode of transfer of microorganisms from the light handle into the patient wound is possible in the event the clinician touches the handle and then the sterile field. no adverse events have been reported.
  • 조치
    Covidien is requesting the customers to immediately quarantine and discontinue use of the affected devices. Replacement product is not available at this time and Covidien will be issuing credit for the returned, unused and unexpired device(s). This action has been closed-out on 08/08/2016.

Device

Devon Light Glove
  • 모델명 / 제조번호(시리얼번호)
    Devon Light GloveItem Number and Item Description 571711 NS-3600-B LITE GLOVE31140208 3611 LITE GLOVE31140216 3613 LITEGLOVE CS19231140257 3612 THEATRE LITE GLOVELot numbers beginning with 508xxxx or lowerManufactured: March 2012 through March 2015ARTG number: 186761
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA