Events

Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Western / Scott Fetzer Company 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
    68466
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1849-2014
  • 사례 시작날짜
    2014-04-07
  • 사례 출판 날짜
    2014-06-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127979
  • 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
    Regulator, pressure, gas cylinder - Product Code CAN
  • 원인
    Separation events have occurred, including the vipr separating from the aluminum cylinder.
  • 조치
    All initial consignees of subject product were notified by letter dated June 5, 2014 via U.S. mail. Initial consignees were directed to forward copies of the recall notification letters to their contacts in the event the subject product has been further distributed.

Device

Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
  • 모델명 / 제조번호(시리얼번호)
    Model numbers AGI-4430, ALQ-1877, ALQ-1878, ALQ-1967, ALQ-2033, ALQ-2041, INW-5153, PRX-9310, PRX-9415, PRX-9416, PRX-9416L, PRX-9427, PRX-9427L, RG3001, RG3003, RG4004, RG4004B, RMI-9672, VIT-11660, XRA-3100, XRA-3110, XRA-3110F, XRA-3120, XRA-3120F, XRA-3130, XRA-3200, XRA-3220, XRA-3230, XRA-3230F, XRA-3300, XRA-3310, XRA-3320, XRA-3320F, XRA-3330, XRA-3330F, XRA-3400, XRA-3420, XRA-3420F, XRA-3430, XRA-3430F, XRA-4400, XRA-4430, and XRA-4430P.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia and the countries of Canada,China, Costa Rica, France, Honduras, India, Ireland, Italy, Japan, Korea (South), Malaysia, Panama, Spain and Taiwan.
  • 제품 설명
    Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
  • Manufacturer
    Western / Scott Fetzer Company

Manufacturer

Western / Scott Fetzer Company
  • 제조사 주소
    Western / Scott Fetzer Company, 875 Bassett Rd, Westlake OH 44145-1142
  • Source
    USFDA