Events

Device Recall FastCath" Transseptal Guiding Introducer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St Jude 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
    63855
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0617-2013
  • 사례 시작날짜
    2012-03-28
  • 사례 출판 날짜
    2012-12-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114913
  • 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
    Introducer, catheter - Product Code DYB
  • 원인
    St. jude medical is recalling a single batch of fast cath transseptal guiding introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
  • 조치
    St Jude Medical hand delivered the" Product Recall" letter dated March 27, 2012, to the affected customers on April 5, 2012, and March 28, 2012. The letter identified the product, the problem and the action needed to be taken by the customer. The returned devices and those not distributed were quarantined at the SJM Minnetonka distribution center until their destruction. Customers were requested to to complete and return the reconciliation form. Further questions please call (651) 756-6526

Device

Device Recall FastCath" Transseptal Guiding Introducer
  • 모델명 / 제조번호(시리얼번호)
    Model no. 406586 Batch no. 3619533
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution only including the states of FL, KY and OK.
  • 제품 설명
    Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 || Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
  • Manufacturer
    St Jude Medical Inc

Manufacturer

St Jude Medical Inc
  • 제조사 주소
    St Jude Medical Inc, 177 E County Road B, Saint Paul MN 55117-1951
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA