Events

Device Recall NAMIC Fluid Delivery Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics Inc. (Navilyst Medical 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
    76347
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1853-2017
  • 사례 시작날짜
    2017-01-13
  • 사례 출판 날짜
    2017-03-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152938
  • 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
    The product has the potential to be non-sterile as it was not packaged in accordance to specification.
  • 조치
    On January 13, 2017 Navilyst Medical initiated a recall action by contacting the 6 consignees by telephone and directing them to stop using the affected product and segregate until receipt of written Recall Notification. Recall Notifications dated January 19, 2017 were delivered by Federal Express to these consignees on January 20, 2017. Per the Recall Notification, Consignees are instructed to segregate and return all affected devices to Navilyst Medical, Inc. (an AngioDynamics Company) and complete and return the Reply Verification Tracking Form, provided in the recall notification.

Device

Device Recall NAMIC Fluid Delivery Set

Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)
  • 제조사 주소
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • 제조사 모회사 (2017)
    AngioDynamics Inc
  • Source
    USFDA