Events

Device Recall HEARTSTRING Aortic Cutter 4.3 mm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Cardiovascular 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
    56860
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1222-2011
  • 사례 시작날짜
    2010-06-04
  • 사례 출판 날짜
    2011-02-11
  • 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=94678
  • 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
    Surgical Cutter - Product Code FZT
  • 원인
    Pouch integrity may be compromised, resulting in loss of sterility.
  • 조치
    Urgent Device Removal letters were sent out on June 10, 2020 by Federal Express. The letter identified the affected product, described the reason for the recall, and asked for all affected product to be returned. The firm asked customers to examine their inventory and to discontinue distributing the affected lots. In addition, customers are to complete and return the Field Action Response form. If the affected product was further distributed, those customers also need to be notified of the recall and return their affected product to their distributor. All affected returned products may be exchanged with other unaffected HEARTSTRING Aortic Cutter 4.3 MM devices. Customers are to contact their local MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874 to arrange for an exchange and if they have any questions.

Device

Device Recall HEARTSTRING Aortic Cutter 4.3 mm
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 9081071 and 9082071.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of IA, KY, IL, WI, TX and NC and countries of Japan, Germany and Hong Kong.
  • 제품 설명
    Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey. || Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel.
  • Manufacturer
    Maquet Cardiovascular

Manufacturer

Maquet Cardiovascular
  • 제조사 주소
    Maquet Cardiovascular, 170 Baytech Dr, San Jose CA 95134-2302
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA