Events

Rappel de Device Recall SmartSite Low Sorbing Infusion Set

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 CareFusion 303, 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
    66150
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2279-2013
  • Date de mise en oeuvre de l'événement
    2013-08-30
  • Date de publication de l'événement
    2013-09-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-10-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121570
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    Carefusion is recalling the smartsite low sorbing infusion set, model 72313e, lot number 13016314, because of an incorrect filter was assembled on this lot. the correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.
  • Action
    CareFusion sent an Urgent Medical Device Recall Notification dated August 30, 2013, to all affected customers. The letter informed the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers were instructed to immediately check their inventory for the affected product, if any affected product is encountered, customers were instructed not to use. Customers were instructed to complete the customer response form and return the form to CareFusion with the affected product for replacement.. A distributor letter was also sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors were instructed to contact the Customer Support Team, return customer response form, and if they have questions then they were instructed to contact the CareFusion Support Center at 1-800-562-6018. For questions regarding this recall call 858-617-4000.

Device

Device Recall SmartSite Low Sorbing Infusion Set
  • Modèle / numéro de série
    Lot Number 13016314
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA, FL, AZ, and TN
  • Description du dispositif
    SmartSite Low Sorbing Infusion Set, Model#72313E || The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • Adresse du fabricant
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA