Events

Device Recall Runthrough NS Guidewire 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
    59051
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2858-2011
  • 사례 시작날짜
    2011-06-03
  • 사례 출판 날짜
    2011-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100937
  • 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
    Wire, guide, catheter - Product Code DQX
  • 원인
    Baloon catheter guidewires may become uncoiled during angioplasty procedures.
  • 조치
    Terumo Medical Corporation initiated contacting consignees on June 3, 2011 via an in-person visit to hand deliver an "URGENT PRODUCT BULLETIN: TERUMO PRODUCT SAFETY ALERT" letter dated June 3, 2011. The letter emphasized to consignees the importance of following the current instructions and recommendations provided to minimize the potential for damage during use and removal of the recalled product. For further questions, please contact your Terumo Territory Manager or call (800) 283-7866 and ask to speak with the Runthrough NS Guidewire Product Manager, at extension 4129.

Device

Device Recall Runthrough NS Guidewire
  • 모델명 / 제조번호(시리얼번호)
    Lot 101028, exp 2013 - 09
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide (USA) Distribution -- including the states of: CT, GA, and SC.
  • 제품 설명
    Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH || Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA)
  • 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