Events

Rappel de Device Recall Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip

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
    72024
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2732-2015
  • Date de mise en oeuvre de l'événement
    2015-08-24
  • Date de publication de l'événement
    2015-09-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139591
  • 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 - Product Code KOD
  • Cause
    Potential breach of the sterile barrier packaging.
  • Action
    The firm, Bard, sent an "URGENT: MEDICAL PRODUCT RECALL" letter dated August 20, 2015 to customers via FedEx on 8/24/2015. The letter describes the product, problem and actions to be taken. The customers were instructed to not use or further distribute any affected product; check inventory and remove any identified affected product from your shelves; complete and return the Recall and Effectiveness Check Form by September 19, 2015, even if you have used or no longer have possession of the affected product, via fax to 1-770-784-6469 or email a scanned copy to Regan.Gealy@crbard.com ( if you cannot fax or email the form, call 1-770-784-6471 and report the required information verbally); and if you have further distributed any units of the affected lot, identify your customers and notify them at once of this product recall, and return product to Bard Medical Division, 8195 Industrial Blvd., Covington, GA 30014. BMD will provide replacement product or credit for your return product. If you have any questions, please call Vice President, Quality Assurance at 770-784-6119.

Device

Device Recall Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip
  • Modèle / numéro de série
    Lot Number 53621456
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.
  • Description du dispositif
    Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. || Used as an Intermittent Urinary Catheter
  • 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