Events

Tucker Embryo Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fertility Technology Resources, 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
    45413
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0665-2008
  • 사례 시작날짜
    2007-09-13
  • 사례 출판 날짜
    2008-01-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-02-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67034
  • 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
    Assisted Reproduction Catheters - Product Code MQF
  • 원인
    Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
  • 조치
    All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.

Device

Tucker Embryo Catheter
  • 모델명 / 제조번호(시리얼번호)
    All units shipped before August 17, 2007
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide: USA including states of CA, CO, FL, GA, LA, MD, ME, MI, MS, NC, NH, NJ, NY, OH, TN, and WA and The Netherlands.
  • 제품 설명
    Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062
  • Manufacturer
    Fertility Technology Resources, Inc.

Manufacturer

Fertility Technology Resources, Inc.