Events

Device Recall Dynarex CGA870 All Brass Oxygen RegulatorAll Brass 025 LPM, Barb & 2DISS Outlet 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dynarex Corporation 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
    80058
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1955-2018
  • 사례 시작날짜
    2018-05-08
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164303
  • 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
    The device is equipped with a dial that has an inaccurate flow rate indicator.
  • 조치
    The Firm sent an Urgent Medical Device Recall letter on May 8, 2018. Customers were instructed : Customer/User should stop distributing/using product immediately. Customer/User is to complete the attached Medical Device Recall Return Response Acknowledgement and Receipt Form and return immediately using the fax number or email address on the form. After returning the form, please contact Dynarex Returned Goods Representative (see contact information on attached for or under (8) below) to return the product and to receive credit for the product. For further questions, please call ( 845 ) 365-8200.

Device

Device Recall Dynarex CGA870 All Brass Oxygen RegulatorAll Brass 025 LPM, Barb & 2DISS Outlet
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 37979
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : MA and NJ
  • 제품 설명
    Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 || A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • 제조사 주소
    Dynarex Corporation, 10 Glenshaw St, Orangeburg NY 10962-1207
  • 제조사 모회사 (2017)
    Dynarex Corporation
  • Source
    USFDA