Device Recall Praxair Vantage Grab n Go 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Praxair 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
    63729
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0525-2013
  • 사례 시작날짜
    2012-11-16
  • 사례 출판 날짜
    2012-12-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-03-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Isolated incidents of ignition inside grab n' go cylinders that had been knocked over or otherwise subject to significant physical impact.
  • 조치
    The firm, PRAXAIR, sent a "MEDICAL DEVICE CORRECTION" letter dated November 26, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the Grab'n Go operating instructions provided in the letter which include: storing the Grab'n Go systems indoors in a safe area; never store a system in an elevated location; handle systems safely and avoid jarring or dropping the system and locate at the following web link: www.praxair.com/GNGinstructions. The customers were also instructed to ensure that all of the Grab'n Go units that were sent by Praxair are sent to Praxair for servicing and refilling after use, in accordance with their normal process. If you have any questions, contact your sales representative at 630-320-4452 or email: Thelma_Brantley@Praxair.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    OX M-AEGNGVNTG (US and Canada) and WESPRX-9500 (Global)  Cyclinders in service since Jan 2009. Units with a "T" decal (T-teflon) on the fill side of the valve have the rework completed.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.
  • 제품 설명
    Praxair Vantage Grab n Go - Gas Cylinder pressure regulator || Catalog Number: OX-M-AEGNGVNTG || Usage: Regulator reduces pressure in oxygen-containing cylinder.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Praxair Inc., 39 Old Ridgebury Road, Danbury CT 06817-0001
  • 제조사 모회사 (2017)
  • Source
    USFDA