Events

Device Recall Marquet Heartstring II Proximal Seal System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Cardiovascular, LLC 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
    56868
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0940-2011
  • 사례 시작날짜
    2010-05-05
  • 사례 출판 날짜
    2011-02-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94744
  • 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
    Clamp, vascular - Product Code DXC
  • 원인
    Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
  • 조치
    The firm, MAQUET Getinge Group, sent an "URGENT DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 5, 2010, to all customers via Federal Express. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to immediately examine their stocks to determine if they have any of the affected product, if found, discontinue dispensing (distributing) the lot and complete the Field Action Response Form; immediately contact accounts if they acted as a distributor, and acknowledge receipt of this notification whether or not they have any affected products by completing the Field Action Response Form via fax to (U.S.): 1-888-899-2874. If you have any additional questions, please contact your local MAQUET Cardiovascular sales representative or our Customer Service at 1-888-880-2874.

Device

Device Recall Marquet Heartstring II Proximal Seal System
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045, 25005622
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
  • 제품 설명
    Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ || Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • 제조사 주소
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA