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
    68608
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2025-2014
  • Date de mise en oeuvre de l'événement
    2014-06-17
  • Date de publication de l'événement
    2014-07-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128305
  • 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 because they were assembled with a drip chamber that consist of a 15 micron filter. the directions for use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c.
  • Action
    A recall letter is dated 6/25/14 and will be sent out to customers who purchased the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip chamber. The letter informs the customers of the problems identified, potential risk, and actions to be taken. Customers are instructed to promptly complete and return the enclosed mandatory Customer Response Card to acknowledge the receipt of this communication and to expedite the corrective action process.

Device

Device Recall SmartSite Low Sorbing Infusion Set
  • Modèle / numéro de série
    Lot No. 14035485 14046894 14035458 14035457
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of FL, NM, WA, WI, and TX.
  • Description du dispositif
    SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A || 14035457 || 14035485 || 14046894 || 14035458
  • 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