Events

Coronary Artery Perfusion Cannula with Balloon 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sorin Group USA, 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
    74934
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2757-2016
  • 사례 시작날짜
    2016-08-12
  • 사례 출판 날짜
    2016-09-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148853
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • 원인
    The tip of the cannula should be bent at either a 45 or 90 degree angle. samples have been returned where the angle of the tip is less than the requirement.
  • 조치
    LivaNova issued an Urgent Safety Alert letter via certified mail on August 12, 2016 to all affected customers. The letter instructed customers to check their inventory to determine if the Cannulae belongs to the product code and lots listed. If the customer does not have any of the products described in the communication, please complete the response form below and return it per the instructions indicated on the form; otherwise, please check the tip angle to determine if it is conforming to specifications. If specification is not met, please file a complaint through your normal process whether you decide to keep it and use it or return the product to Sorin Group; if you are not willing to use it, return the affected parts to Sorin Group USA. Please contact Customer Service 1-S00-650-2623 or email CustomerService@livanova.com to have a Return Material Authorization (RMA) issued. Complete the Customer Response Form attached to this letter to acknowledge receipt of this letter. Please return this form no later than September 15, 2016. For questions regarding this recall call 303-467-6306.

Device

Coronary Artery Perfusion Cannula with Balloon
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1425900137, 1433900079, 1433900080, 1435300088.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.
  • 제품 설명
    Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • 제조사 주소
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
  • 제조사 모회사 (2017)
    LivaNova PLC
  • Source
    USFDA