Events

Rappel de Integra Licox Test Kit

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 Integra LifeSciences Corp..

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
    68159
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1675-2014
  • Date de mise en oeuvre de l'événement
    2014-04-16
  • Date de publication de l'événement
    2014-05-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127071
  • 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
    Device, monitoring, intracranial pressure - Product Code GWM
  • Cause
    Integra lifesciences has identified through a small number of complaints that some lot numbers of licox test kits (catalog number bc10r) may provide erroneous "calibration test failure" message when they are used with the licox pto2 monitor (lcso2, or may provide an erroneous out of range result with the licox cmp brain tissue oxygen and temperature monitor (ac31).
  • Action
    Integra sent an "Urgent Voluntary Medical Device Recall/Return Response form notifications dated April 16, 2014 to US customers via traceable courrier service and to non-US customers via traceable email or facsimile. The customer notification advises them of the nature of the issue and the potential for adverse patient consequences; advises them to review their inventory and if they have BC10R Test Kit Resistors with an affected lot number to immediately stop using it; requests they identify and report to Integra if they do or do not have any affected BC10R affected lot numbers; and advises them how to return any affected products in their possession. Customers with questions were instructed to call 1-855-532-1723.

Device

Integra Licox Test Kit
  • Modèle / numéro de série
    Catalog Number BC10R Lot Nos: 051113, 100913, 140513, 161013, 25013
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including Illinois, Florida, Maryland, Massachusetts, North Carolina, Pennsylvania, South Dakota and Internationally to Australia, Austria, Belgium, Chile, Finland, Germany, Great Britain, Greece, Israel, Italy and Russia.
  • Description du dispositif
    Integra Licox Test Kit REF BC10R Rx Only || An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.