Events

FIRE STAR RX PTCA DILATATION CATHETER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    15560
  • 사례 위험등급
    I
  • 사례 시작날짜
    2008-01-14
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    The potential to exhibit slow or no deflation which could result in total occlusion of the vessel and lead to arrhythmias ventricular fibrillation acute myocardial infarction or injury to the coronary artery.

Device

FIRE STAR RX PTCA DILATATION CATHETER
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 801-10250 (Lot serial: 13173912 thru 13315455); Model Catalog: 801-1020S (Lot serial: 13173912 thru 13315455); Model Catalog: 801-30250 (Lot serial: 13173912 thru 13315455); Model Catalog: 801-30225 (Lot serial: 13173912 thru 13315455); Model Catalog: 801-3020S (Lot serial: 13173912 thru 13315455); Model Catalog: 801-3020D (Lot serial: 13173912 thru 13315455); Model Catalog: 801-20350 (Lot serial: 13173912 thru 13315455); Model Catalog: 801-20325 (Lot serial: 13173912 thru 13315455); Model Catalog: 801-20300 (Lot serial: 13173912 thru 13315455); Model Catalog: 801-20275 (Lot serial: 13173912 thru 13315455); Model Catalog: 801-20250 (Lot serial: 13173912 thru 13315455); Model Catalog: 801-20225 (Lot serial: 13173912 thru 13315455); Model Catalog: 801-2020S (Lot serial: 13173912 thru 13315455); Model Catalog: 801-2020D (Lot serial: 13173912 thru 13315455); Model Catalog: 801-2015S (Lot serial: 13173912 thru 13315455); Model Catalog: 801-2015D (Lot serial: 13173912 thru 13315455); Model Catalog:
  • 의료기기 분류등급
    Cardiovascular Devices
  • 제품 설명
    FIRE STAR RX PTCA DILATATION CATHETER
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.