Events

Device Recall Guardian II NC Hemostasis Valve with Guidewire Introducer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vascular Solutions, 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
    63098
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2400-2012
  • 사례 시작날짜
    2012-08-30
  • 사례 출판 날짜
    2012-09-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112542
  • 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
    Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
  • 원인
    Vascular solutions, inc., became aware of a potential problem involving pouches missing a seal from guardian ii (model 8210) and guardian ii nc (model fh102) hemostasis valve which poses a risk of product contamination.
  • 조치
    The firm, Vascular Solutions, sent an "URGENT - Medical Device Field Safety Notice" dated August 24, 2012 and a follow-up "Urgent Medical Device Removal - Lot Specific" letter dated August 30, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their inventory and to follow steps outlined in the letter which included to complete and return the "VSI Account Inventory Form" via email to: customerservice@vasc.com or fax: to (763) 656-4251. If you have specific questions or concerns regarding this matter, please contact your local Vascular Solutions Account Manager; call (763) 656 4300 or email: Senior Regulatory Operations Associate at SOuellette@vasc.com and/or email: www.vascularsolutions.com.

Device

Device Recall Guardian II NC Hemostasis Valve with Guidewire Introducer
  • 모델명 / 제조번호(시리얼번호)
    lots 27686, 27293, 22446
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea. Italy, Korea
  • 제품 설명
    Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. || Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • 제조사 주소
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA