Rappel de Device Recall INOmax DS (Delivery System)

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 Ino Therapeutics.

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
    60258
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0583-2012
  • Date de mise en oeuvre de l'événement
    2010-11-30
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-05-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Apparatus, nitric oxide delivery - Product Code MRN
  • Cause
    Through the review and monitoring of its complaint data, ikaria identified a product anomaly with the inomax ds model 1003. ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). during a subsequent level 3 inspection by fda, it was concluded that the action should have been reported under 21 cfr & 806.10.
  • Action
    Ikaria sent a "RECALL- CUSTOMER PRODUCT REMEDIATION" notice dated December 22, 2011 to all affected customers. The letter describes the product, problem, actions taken by the firm. No action was required by customers. The notice served as correspondence to inform customers of the issue. Customers may direct their questions to Ikaria Customer Care at 1-877-566-9466.

Device

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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of MALAYSIA.
  • Description du dispositif
    INOmax DS (Delivery System) Model 10003 & 10007. || The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Ino Therapeutics, 2902 Dairy Dr, Madison WI 53718-3809
  • Société-mère du fabricant (2017)
  • Source
    USFDA