Events

Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Sodium Chloride Dressing Covidien Curity Eye Pad 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-2017-RN-00354-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00354-1
  • 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
    There is a potential for the sterile packaging of the covidien curity eye pad, curity eye pad oval and curity sodium chloride dressing to be compromised. hence, the use of products with this issue may result in an increased risk of infection. to date, there have been no reports of infection associated with this issue.
  • 조치
    Medtronic is advising customers to quarantine and discontinue the use of affected stock. Customers are also requested to label the stock with the provided ZRE # (number) prior to their return to Medtronic whereby customers will receive credit to the value of the returned stock.

Device

Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Sodium Chloride Dressing Covidien Curity Eye...
  • 모델명 / 제조번호(시리얼번호)
    Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Sodium Chloride Dressing Covidien Curity Eye Pad Item Code: 03201Lot Numbers beginning with 12, 13, 14, 15 and16Covidien Curity Eye Pad OvalItem Code: 2841Lot Numbers beginning with 12, 13, 14, 15 and16Covidien Curity Sodium Chloride Dressing Item Code: 3339Lot Number beginning with 14, 15, 16 (Excluding lots: 16J098062, 16J098162, 16J098262)ARTG Numbers: 186368, 186373
  • 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