Events

Rappel de Device Recall CODMAN CERTAS Programmable Valves

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 Codman & Shurtleff, 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
    67793
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1468-2014
  • Date de mise en oeuvre de l'événement
    2013-12-13
  • Date de publication de l'événement
    2014-04-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-04-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126333
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Cause
    Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted codman certas programmable valves.
  • Action
    Codman Neuro issued notification packages dated 12/13/13 to Domestic Hospitals and international accounts. Specific letters and associated inclusion of the additional aids, include A) a valve setting verification guide with instructions for use with x-ray images, and B) a plastic valve cut out overlay). A response reply form was included to be completed and returned to confirm effectiveness of the notification.

Device

Device Recall CODMAN CERTAS Programmable Valves
  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: || 82-8800 In Line Valve Only || 82-8801 In Line Valve with Catheter and Accessories || 82-8802 In Line Valve with Unitized Catheter and Accessories || 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories || 82-8804 In Line Valve only with SIPHONGUARD Device || 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories || 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories || 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories || 82-8850 Certas Therapeutic Management System
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Adresse du fabricant
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA