Events

Rappel de Device Recall Intelliport Medication Management 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 Becton Dickinson & Company.

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
    73008
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1076-2016
  • Date de mise en oeuvre de l'événement
    2015-12-09
  • Date de publication de l'événement
    2016-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142710
  • 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
    Infusion safety management software - Product Code PHC
  • Cause
    The sterility of the product cannot be assured. this may result in increased risk of infection.
  • Action
    Becton Dickinson representatives notified their customers in person and a copy of the "Urgent Product Recall" letter and "Recall Response Form" dated 12/9/2015 was provided. The letter identified the reason for the recall; how to identify affected product; and the actions to be taken. The letter instructed customers to immediately review their inventory; complete the enclosed Recall Response Form and fax (1-201-847-4267 it to BD or email it to Becky_Saggau@bd.com even if you do not have any of the affected lot; and return all affected products with the completed Recall Response Form following instructions on the enclosed packing instruction. If customers have any questions or require assistance with the return of the recalled product and/or availability of replacement product, they were instructed to contact 1-201-847-4267 between 8AM and 5 PM ET Monday through Friday.

Device

Device Recall Intelliport Medication Management System
  • Modèle / numéro de série
    Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to:California and Utah.
  • Description du dispositif
    BD Intelliport Medication Management System Sensor || The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Adresse du fabricant
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA