Events

Device Recall Sure T 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Unomedical As 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
    71332
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1821-2015
  • 사례 시작날짜
    2015-05-21
  • 사례 출판 날짜
    2015-06-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137324
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Set, administration, intravascular - Product Code FPA
  • 원인
    Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
  • 조치
    Each consignee was sent an "Urgent Field Safety Notice Regarding Steel Cannula Infusion Sets" on 5/21/2015 via Express Mail. This notification identified the affected product as well as the reason for the recall. It also contained instructions on how to use the product. Customers were to contact their health care provider if they suspected that a needle had broken off and remained under the skin. Diabetic patients were to monitor their blood sugar and non diabetic patients were to monitor symptoms which would indicate drug delivery had failed. Questions should be directed to the persons identified in the letter.

Device

Device Recall Sure T
  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of CA, IL, MN, and PA; and, the countries of Australia, Bahrain, Belgium, Canada, China, Cypress, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Kuwait, Lebanon, Malaysia, Maldives, Oman, Schweiz, South Africa, Spain, Sweden, Switzerland, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset || Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
  • Manufacturer
    Unomedical As

Manufacturer

Unomedical As
  • 제조사 주소
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • 제조사 모회사 (2017)
    Triona Holding Sa
  • Source
    USFDA