Events

Midmark M11 Ultra Steam Sterilizer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Midmark Corportation 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
    60456
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0597-2012
  • 사례 시작날짜
    2011-10-24
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105922
  • 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
    Sterilizer, steam - Product Code FLE
  • 원인
    During and fda inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.
  • 조치
    Midmark Corp. will begin sending customer communications out the week of January 9, 2012 to all affected customers. The letter will describe the product, problem, and actions to be taken by the customers. Additionally, a warning label and an illustration of where to place the label will be included with the letter. Customers may contact the firm at 1-800-643-6275.

Device

Midmark M11 Ultra Steam Sterilizer
  • 모델명 / 제조번호(시리얼번호)
    Model #'s: M11-001, M11D-001, M11-001R, M11D-002, M11-002, M11-002R, M11-003, M11-004, M-005, and M11-006
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution- USA (nationwide) including Puerto Rico and the countries of AUSTRALIA, BELGIUM, BRAZIL, CHILE, CHINA, EGYPT, FRANCE, GUAM, HONG KONG, HUNGARY, ICELAND, INDIA, KOREA, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, POLAND, RUSSIA, SAIPAN MP, SAUDI ARABIA, SEOUL, SINGAPORE, TAIWAN, THAILAND, TURKEY, U.A.E., UNITED KINGDOM and WEST INDIES.
  • 제품 설명
    Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. || Sterilize reusable equipment that is heat and moisture stable.
  • Manufacturer
    Midmark Corportation

Manufacturer

Midmark Corportation
  • 제조사 주소
    Midmark Corportation, 60 Vista Dr, Versailles OH 45380
  • 제조사 모회사 (2017)
    Midmark Corporation
  • Source
    USFDA