Events

Rappel de Device Recall pO2 D999 membrane units

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 Radiometer America Inc.

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
    67044
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0713-2014
  • Date de mise en oeuvre de l'événement
    2013-06-10
  • Date de publication de l'événement
    2014-01-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124601
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Cause
    Radiometer became aware that the regarded lot po2 units 942-042r0971 were produced with inner solution for pco2 membrane units. this solution is a salt solution similar to the po2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following cal2 calibration.
  • Action
    Radiometer sent a Product Notification letter dated June 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and remove any affected product, discard all affected product in their possession, and complete page 2 of the letter and return to their Radiometer representative. Radiometer will replace any quantity of affected product they have at their location. Customers with questions were instructed to contact Radiometer America Technicial Support at 1-800-736-0600, opt 4. For questions regarding this recall call 440-871-8900, ext 209.

Device

Device Recall pO2 D999 membrane units
  • Modèle / numéro de série
    Part #: 942-042, Lot #: R0971
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.
  • Description du dispositif
    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 || pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Adresse du fabricant
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA