Events

Device Recall HydroFinity Guidewire 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nitinol Devices and Components, 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
    68419
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1817-2014
  • 사례 시작날짜
    2014-05-28
  • 사례 출판 날짜
    2014-06-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127557
  • 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
    Reports of outer polymer jacket to the core wire being damaged during use on the hydrofinity guidewire.
  • 조치
    Covidien sent an Urgent Product Recall letter dated May 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused devices to Covidien, their account would be credited. Customers were also instructed to:: 1) Stop using product listed in this letter immediately 2) Segregate this product from other inventory 3) Fill out the reply (verification) form at the end of this letter ¿ If you do not have any product identified in this letter, please fax or email the completed form to Covidien at (877) 523-9109 or covidien8770@stericycle.com. ¿ If you do have product, your sales representative will assist you in completing the verification form and arranging for return of the product. ¿ Please fax the completed form to Covidien (877) 523-9109 or email to covidien8770@stericycle.com. 4) Your sales representative will be available to answer any questions regarding this recall and assist you in completing the verification form, returning product and addressing any account credits. This action is being conducted with the knowledge of the United States FDA and other regulatory authorities. ¿ Customers with questions were instructed to call (202) 310-5120. For questions regarding this recall call 202-310-5120. _

Device

Device Recall HydroFinity Guidewire
  • 모델명 / 제조번호(시리얼번호)
    Model HPRS35260- all lots.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
  • 제품 설명
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Standard Shaft, Straight Tip, 260 CM Length || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
  • Manufacturer
    Nitinol Devices and Components, Inc.

Manufacturer

Nitinol Devices and Components, Inc.