Events

Device Recall Pinnacle Destination Guiding Sheath, 7 French, 90 cm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Medical 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
    58677
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2416-2011
  • 사례 시작날짜
    2010-06-24
  • 사례 출판 날짜
    2011-06-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100090
  • 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
    Introducer, catheter - Product Code DYB
  • 원인
    Molding defect in destination product that render the device unusable.
  • 조치
    Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.

Device

Device Recall Pinnacle Destination Guiding Sheath, 7 French, 90 cm
  • 모델명 / 제조번호(시리얼번호)
    RSC02
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama
  • 제품 설명
    Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 || Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation
  • 제조사 주소
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA