Events

Device Recall EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS 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
    55317
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1607-2010
  • 사례 시작날짜
    2010-03-26
  • 사례 출판 날짜
    2010-05-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90545
  • 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
    prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
  • 원인
    This is an expansion of recall # z-866-2010, adding an additional two lots to the recall of exxcel soft stand wall eptfe vascular grafts due to a labeling mix up.
  • 조치
    The firm, MAQUET Cardiovascular, LLC, sent a "DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated March 23, 2010, to all customers via Federal Express. The letter describes the product, problem and action to be taken by customers. The customers were instructed to examine their stock immediately to determine if they have any of the affected product from the lot, discontinue dispensing the lot and complete and return by fax (973-709-6511) the enclosed Field Action Response Form whether or not they have any affected products. Please contact your local MAQUET cardiovascular sales representative or Customer Service at 1-888-880-2874 for the exchange.

Device

Device Recall EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS
  • 모델명 / 제조번호(시리얼번호)
    UPN M002004948580; Lot 11407455, Exp 12/2010.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of TX, NJ, SC, MO, ID, TN, FL, CA, PA and Canada and Germany.
  • 제품 설명
    EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. || Sterile || Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.
  • 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