Events

Rappel de Magic3

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 C.R. Bard, 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
    75365
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0600-2017
  • Date de mise en oeuvre de l'événement
    2016-10-05
  • Statut de l'événement
    Open, Classified
  • 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=150148
  • 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
    Catheter, urological (antimicrobial) and accessories - Product Code MJC
  • Cause
    Misbranding; the product labeled as an antibacterial hydrophilic intermittent catheter, is instead an antibacterial intermittent catheter (no hydrophilic coating).
  • Action
    Bard Medical sent an Urgent Medical Device Product Recall letter dated October 5, 2016 to customers The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine and quarantine and return affected inventory. Customers were asked to complete and return the accompanying Recall & Effectiveness Check Form attached.

Device

Magic3
  • Modèle / numéro de série
    Product Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of: CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.
  • Description du dispositif
    Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile || Product Usage: || The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. It is packaged with a water sachet that is manually burst to hydrate the catheter coating at time of use. The catheters are packaged in a film-to-film pouch and are sterilized by electron beam irradiation and are distributed as a single use device. The catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction and surgical procedures. Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established. The device is not intended to be used as a treatment for active urinary tract infection. For urological use only; urinary catheters are intended for use for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Adresse du fabricant
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA