Events

Rappel de AirLife Resuscitation

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 Vyaire Medical.

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
    78412
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1574-2018
  • Date de mise en oeuvre de l'événement
    2017-04-27
  • 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=163413
  • 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
    Cardiopulmonary resuscitation aid kit - Product Code OEV
  • Cause
    The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
  • Action
    The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:GMB-GLB-VSFieldActions@CareFusion.com.; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129. For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: Kristina.Scheppa@CareFusion.com.

Device

AirLife Resuscitation
  • Modèle / numéro de série
    Part Number: 2K8039. Lots: 0001002932, 0001018700
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
  • Description du dispositif
    AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve || Product Usage: || The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
  • Manufacturer
    Vyaire Medical

Manufacturer

Vyaire Medical
  • Adresse du fabricant
    Vyaire Medical, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Société-mère du fabricant (2017)
    Vyaire Holding Company
  • Source
    USFDA