Device Recall FMI 105"Oral Surgery Administration Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Churchill Medical Systems, 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
    57295
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1332-2011
  • 사례 시작날짜
    2010-11-16
  • 사례 출판 날짜
    2011-02-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-05-01
  • 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
    Set, administration, intravascular - Product Code FPA
  • 원인
    Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
  • 조치
    The firm, Churchill Medical/Vygon, sent an "URGENT MEDICAL DEVICE RECALL" letter dated November 16, 2010, via overnight mail to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their stock for affected product; immediately cease use and distribution and quaratine the affected product; contact Vygon's Customer Service Department at 1-800-473-5414 for a return Merchandise Authorization number; complete and return the Recall Acknowledgement and Inventory Return Form via fax to 215-390-2019 and mail return product with form to: Vygon, 103A Park Drive, Montgomeryville, PA 18936, and if the customer is a distributor, they were to provide their customers with a copy of this notification and attached form. Note: An additional follow up communication will be provided to the customers after reconciliation of the returned inventory and all inventory will be credited or replaced. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 1010066
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.
  • 제품 설명
    FMI 105"Oral Surgery Administration Set; || Item AMS-468-1 || Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322 || Intended use: Intravascular Administration Set
  • Manufacturer

Manufacturer