Events

Device Recall Possis AngioJet Rheolytic Thrombectomy SystemSpiroflex Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Possis Medical, 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
    37919
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0954-2007
  • 사례 시작날짜
    2007-05-01
  • 사례 출판 날짜
    2007-06-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-07-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52238
  • 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
    Coronary Catheter - Product Code MCX
  • 원인
    Mislabeling: xmi (otw) catheters were mislabeled as xmi-rx units and avx catheters were mislabeled as spiroflex catheters.
  • 조치
    Consignees were notified of the problem on May 1, 2007 via a Urgent Medical Device Recall Letter. The consignees were instructed to quarantine the product until a Possis Representative contacts them. The representative will examine the units and determine which ones to be returned to Possis. They were also asked to fill and return the attached form.

Device

Device Recall Possis AngioJet Rheolytic Thrombectomy SystemSpiroflex Catheter
  • 모델명 / 제조번호(시리얼번호)
    Model #: 105835-001 Lot # 73082
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide including states of AK, AR, AZ, CA, CT, FL,IL, IN, KY, MD, ME, MI, MN, MS, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, WA, and WI.
  • 제품 설명
    Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA- || (Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).
  • Manufacturer
    Possis Medical, Inc

Manufacturer

Possis Medical, Inc
  • 제조사 주소
    Possis Medical, Inc, 9055 Evergreen Blvd Nw, Minneapolis MN 55433-5833
  • Source
    USFDA