Device Recall CORE Trumpet Handpiece only 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ConMed Corporation 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
    74774
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0135-2017
  • 사례 시작날짜
    2016-06-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-06-07
  • 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
    Catheter, peritoneal - Product Code GBW
  • 원인
    The packaging seal may contain a crease. the crease may result in an open channel. these channels may compromise sterility of the product.
  • 조치
    ConMed sent an Urgent Device Recall letter dated June 27, 2016, to all affected customers with reply forms via USP First Class Mail. International customers received a notice dated July 11, 2016 by courier service. Customers were advised to inspect their inventory for any of the devices subject to recall. Customers were urged to contact all departments within their facility and any other facilities within their organization that may have received affected products. It is imperative that all end users of these devices receive the notification. Customers who have received any of the affected product are asked to complete and return the reply form along with the device to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac. Please do not return used devices. Replacement product will be issued unless otherwise requested. If customers do not have any affected devices to return, complete and return the business reply form indicating they have no devices and return by one of the means listed:1. Email to: coresihp@conmed.com 2. Fax to: Field Action Support Team at 315-624-3225. 3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team. Customers with questions or requests, should contact the Field Action Support Team at 315-624-3237, fax to 315-624-3225, or email coresihp@conmed.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Beginning Lot Code 110609X to Ending Lot Code 20160308X
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
  • 제품 설명
    CORE¿ Trumpet Handpiece only, Catalog Number CD8450 || The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
  • Manufacturer

Manufacturer

  • 제조사 주소
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • 제조사 모회사 (2017)
  • Source
    USFDA