Events

Rappel de Device Recall CareFusion SmartSite Gravity Blood 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
    64204
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0832-2013
  • Date de mise en oeuvre de l'événement
    2012-12-20
  • Date de publication de l'événement
    2013-02-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115553
  • 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¿ gravity blood set as a result of a potential for separation at the connection of the drip chamber and tubing . the separation may be observed at priming or observed during use. if a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
  • Action
    Carefusion sent an "URGENT: Medical Device Recall Notification" letter dated January 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to return all recalled product directly to the distributor from whom it was purchased immediately, complete and return the enclosed pre-addressed and postage paid mandatory Customer Recall Response Card and to contact your distributor directly, or call the Carefusion Support Center, if you have any questions. For questions Recall Related Questions contact CareFusion Support Center at 888-562-6018; 7am to 4pm (Pacific). For technical questions contact Technical Support at 888-812-3229, 7am to 5pm (Pacific).

Device

Device Recall CareFusion SmartSite Gravity Blood Set
  • Modèle / numéro de série
    Lot number 12055225
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
  • Description du dispositif
    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
  • Manufacturer
    Carefusion 303 Inc

Manufacturer

Carefusion 303 Inc
  • Adresse du fabricant
    Carefusion 303 Inc, 3750 Torrey View Ct, San Diego CA 92130-2622
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA