Device Recall Umbilicup 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DeRoyal Industries Inc 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
    61434
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1398-2012
  • 사례 시작날짜
    2012-01-20
  • 사례 출판 날짜
    2012-04-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-07-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Container, empty, for collection & processing of blood & blood components - Product Code KSR
  • 원인
    Device's needle may become dislodged from the cup during shipment or during use.
  • 조치
    DeRoyal Industries sent Recall communication by letter to all affected consignees of the Non-Sterile Bulk and Single Sterile Units on January 20, 2012 and of the Kits and Trays on Febraury 6, 2012. The letters identified the affected products, problem and actions to be followed. Customers were instrructed to complete the enclosed Notice of Destruction form and return this form by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available. Distributors were instructed to forward this recall to any of their end users that may have affected product. If you have questions or need assistance with the recall, please call 865.362.1020 or Robby Lockett at 865.362.1034.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 17486924, 17920399, 18040342, 18316290, 18551118, 19341884, 19396771, 19464008, 19504031,  19546960, 19743023, 20687057, 21157488, 21413621, 21699341, 22142544, 22373051, 22688811,  23111424, 23161430, 23434063, 23794510, 24095551, 24163955, 24296281, 24451957, 24508634,  24793826, 25043550, 25313548, 25439757, 25747451, 26023059, 26199281, 26544541, 26611133, 26706327, 26943568, 27105291, 27304418, 27571604
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.
  • 제품 설명
    DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 || Product Usage: Collection of cord blood
  • Manufacturer

Manufacturer

  • 제조사 주소
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • 제조사 모회사 (2017)
  • Source
    USFDA