Events

LeMaitre 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 LeMaitre Vascular, 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
    74880
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2544-2016
  • 사례 시작날짜
    2016-08-03
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148670
  • 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
    Valvulotome - Product Code MGZ
  • 원인
    Wire which deploys the loop may be come detached at the handle causing the device to be inoperable.
  • 조치
    LeMaitre Vascular, Inc. sent an Urgent Medical Device Recall letter dated June 29, 2016 to customers via priority mail. The letter identified the affected product, problem and actions to be taken. Customers were requested to locate, quarantine and return the devices. Customers were instructed to complete and return the response form to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product will be requested to be returned and replaced. For questions call 781-221-2266 ext. 183.

Device

LeMaitre
  • 모델명 / 제조번호(시리얼번호)
    Lot Number Exp Date ELVH1078V¿ 2020-10 ELVH1079VA 2020-10
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -  US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.
  • 제품 설명
    1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile || REF# 1009-00J || Product Usage: || The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
  • Manufacturer
    LeMaitre Vascular, Inc.

Manufacturer

LeMaitre Vascular, Inc.
  • 제조사 주소
    LeMaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • 제조사 모회사 (2017)
    LeMaitre Vascular, Inc.
  • Source
    USFDA