Device Recall RUSCH 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Teleflex Medical 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
    59356
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2941-2011
  • 사례 시작날짜
    2011-06-30
  • 사례 출판 날짜
    2011-08-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-04-29
  • 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, urological - Product Code KOD
  • 원인
    Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
  • 조치
    Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990

Device

  • 모델명 / 제조번호(시리얼번호)
    Product number: 238500180, Lot numbers: 115011, 117525, 118749, 119908, 139556, 142682, 145821, 321992, 335513, 342041, 359271, 364044, 370082, 371414, 380177, 380254, 381728 and 874602.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution and (USA) Nationwide Distribution.
  • 제품 설명
    RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 18 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC. || Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • 제조사 모회사 (2017)
  • Source
    USFDA