Events

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

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Dynarex Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    80058
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1955-2018
  • Date de mise en oeuvre de l'événement
    2018-05-08
  • Statut de l'événement
    Completed
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164303
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Regulator, pressure, gas cylinder - Product Code CAN
  • Cause
    The device is equipped with a dial that has an inaccurate flow rate indicator.
  • Action
    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
  • Modèle / numéro de série
    Lot number: 37979
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : MA and NJ
  • Description du dispositif
    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
  • Adresse du fabricant
    Dynarex Corporation, 10 Glenshaw St, Orangeburg NY 10962-1207
  • Société-mère du fabricant (2017)
    Dynarex Corporation
  • Source
    USFDA