Events

Device Recall AngioJet XMI RX 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
    34214
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0469-06
  • 사례 시작날짜
    2005-12-12
  • 사례 출판 날짜
    2006-02-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-11-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43283
  • 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
    Catheter, Embolectomy - Product Code DXE
  • 원인
    It was reported that the catheter model inside the product tray and box was not an xmi rx plus, but an xmi over-the-wire model.
  • 조치
    An Advisory Notice was emailed to OUS Distributors 12/12/2005. The Advisory identifies the product, reason for recall and action Distributor should take. Distributors are to notify their customer who received the affected lot and return it to the Distributor. The Distributor is to open the outer box and inspect the catheter inside the sterile tray. Mislabeled units are to be returned to Possis.

Device

Device Recall AngioJet XMI RX
  • 모델명 / 제조번호(시리얼번호)
    model number: 105421-002, Lot number 56594
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Lot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands.
  • 제품 설명
    AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 USA.
  • Manufacturer
    Possis Medical, Inc

Manufacturer

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